| Primary | Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported. | Intent-to-treat (ITT) population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panels 1 and 2 alone. | Posted | | Mean | 80% Confidence Interval | percentage of HBsAg hepatocytes | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. | | OG001 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-78.46(-94.078 to -42.936)
- OG001-5.68(-15.846 to -0.885)
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| Primary | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | Liver concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 - Molecules of JNJ-73763989 and JNJ-87719164 [M65; deaminated metabolite of JNJ-73763976]) at Week 12 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | nanograms per gram (ng/g) | | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Primary | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | Liver concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; deaminated metabolite of JNJ-73763976]) at Week 40 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | ng/g | | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Primary | Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | Plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 12 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | nanograms per milliliters (ng/mL) | | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Primary | Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40 | Plasma concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 40 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure (OM) was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | ng/mL | | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Primary | Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12 | Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 12 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | ratio | | Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Primary | Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40 | Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 40 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | ratio | | Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 2 at Follow-up Week 48 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 2 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 2 was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is <0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is <0.2. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this OM. | Posted | | Number | | Percentage of participants | | Follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance | Percentage of Participants who achieved HBsAg Seroclearance were reported. HBsAg seroclearance was defined as quantitative HBsAg \ | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. | | OG001 | FU Phase: Panel 2 |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance | Percentage of Participants who achieved HBeAg Seroclearance were reported. HBeAg seroclearance was defined as (quantitative] HBeAg \ | ITT population: participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. "N"(Number of participants analyzed) = number of participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status). | Posted | | Number | | percentage of participants | | Follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. |
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| Secondary | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Hepatitis B Core Antigen Positive (HBcAg+) Hepatocytes at Week 40 | Change from baseline in percentage of intrahepatic viral parameter: HBcAg positive hepatocytes at Week 40 were reported. The percentage of HBcAg positive hepatocytes were derived as number of HBcAg positive hepatocytes*100 per total number of evaluated hepatocytes. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | percent change in HBcAg+ Hepatocytes | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1,and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Covalently Closed Circular Deoxyribonucleic Acid Positive (cccDNA+) Hepatocytes at Week 40 | Change from baseline in percentage of intrahepatic viral parameter: cccDNA positive hepatocytes were reported. The percentage of cccDNA-positive hepatocytes, were derived as number of cccDNA positive hepatocytes*100 per total number of evaluated hepatocytes. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | percent change in cccDNA+ hepatocytes | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: HBsAg Positive (HBsAg+) Hepatocytes at Week 40 | Change from baseline in percentage of intrahepatic viral parameter: HBsAg positive hepatocytes at Week 40 were reported. The percentage of HBsAg positive hepatocytes were derived as number of HBsAg positive hepatocytes * 100 per total number of evaluated hepatocytes. | ITT population included participants who were randomly assigned or enrolled to an intervention arm andreceived at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | percent change in HBsAg+ hepatocytes | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Pre-genomic Ribonucleic Acid Positive (pgRNA+) Hepatocytes at Week 40 | Change from baseline in percentage of intrahepatic viral Parameter: pgRNA positive hepatocytes at Week 40 were reported. The percentage of pgRNA-positive hepatocytes, were derived as number of pgRNA positive hepatocytes*100 per total number of evaluated hepatocytes. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | percent change in pgRNA+ hepatocytes | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1 and 2: Change From Baseline in Transcriptional Activity (Ratio of pg RNA/cccDNA) at Week 40 | Change from baseline in transcriptional activity (ratio of pgRNA/cccDNA) at Week 40 were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Silent Infected Hepatocytes at Week 40 | Change from baseline in percentage of intrahepatic viral parameter: silent infected hepatocytes (that is infected hepatocytes without HBV transcription; cccDNA-positive/HBV RNA-negative hepatocytes) at Week 40 were reported. The percentage of silent infected hepatocytes (SIH), were derived as number of silent infected hepatocytes*100 per total number of evaluated hepatocytes. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | Posted | | Median | Inter-Quartile Range | percent change in SIH | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With HBsAg Seroclearance at Week 72 Without Restarting Nucleos(t)Ide Analog (NA) Treatment | Percentage of participants with HBsAg seroclearance (defined as HBsAg < LLOQ: 0.05 IU/mL) at Week 72 without restarting NA treatment were reported. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | At Week 72 (24 weeks after completion of all study drugs at Week 48) | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48) all Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. | |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 1 at Follow-up Week 48 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 1 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 1 was defined as: for participants with data for last follow-up visit (Follow-up Week 48 for participants who did not receive PegIFN-alpha2a or received PegIFN-alpha2a and did not meet NA completion criteria, and last Follow-up visit for participants who received PegIFN-alpha2a and stopped NA during Follow-up): participants who had a >1 log decline in HBsAg response at last scheduled follow-up visit and had an HBsAg <1000 IU/mL at last scheduled follow-up visit, or for participants without data at last follow-up visit: HBsAg values had a >2 log decline at second most recent visit or >1.5 log decline at latest visit (most recent value used) compared to baseline and had an HBsAg <1000 IU/mL at last available timepoint. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. | Posted | | Number | 80% Confidence Interval | Percentage of participants | | Follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 3 at Follow-up Week 48 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 3 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 3 for participants with a >1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is <0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is <0.2 and have an HBsAg <1000 IU/mL at the last available timepoint. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | | Number | 80% Confidence Interval | Percentage of participants | | From follow-up Week 24 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 4 at Follow-up Week 48 | Percentage of participants with sustained (reduction) serum HBsAg response per definition 4 follow-up Week 48 were reported. Sustained serum HBsAg response per definition 4 were classified into 3 categories with respect to the difference between HBsAg level at the last Follow-up timepoint and end of treatment: Increase: >+0.2 log10 IU/mL , stable: within plus or minus (+/-) 0.2 log10 IU/mL, and decrease: >-0.2 log10 IU/mL. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | FU Phase: Panel 1 | After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA <LLOQ:20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU phase, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroconversion | Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg <LLOQ [<0.05 IU/mL]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies [quantitative] <LLOQ [<5 milli-international units per milliliter {mIU/mL}] and a post-baseline assessment >=LLOQ [>=5 mIU/mL]). | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroconversion | Percentage of participants who achieved HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as [quantitative] HBeAg \ | ITT population: participants randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. "N' (number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status). | Posted | | Number | | Percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Off-treatment Virologic Flares Per Derivation 1 | Virologic flare (VF) per derivation 1 was defined only for participants who were off-treatment (period after stopping all study drugs, including NA) and who had HBV DNA<LLOQ (<20 IU/mL) at last observed point on-treatment [OT]); start date of confirmed VF was first date of 2 consecutive visits with HBV DNA >200 IU/mL. End date of same confirmed VF was first date when HBV DNA value returns to <=200 IU/mL or date of NA restart, whichever comes first. Each virologic flare were categorized based on confirmed (that is, 2 consecutive values) peak HBV DNA above any of 3 thresholds within the start and end date of that flare as followed: 20,000 IU/mL, 2,000 IU/mL, and 200 IU/mL. Participants were counted only once for any given flare, regardless of the number of times they actually experienced the flare. | ITT population: participants randomly assigned or enrolled to an intervention arm and received at least 1 dose of drug. Participants were analyzed according to study drug randomly assigned/enrolled. "N" (Number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 1, as no participants met off-treatment criteria (set duration between last dose and last study visit) at final analysis and thus were not considered eligible for analysis. | Posted | | Number | | percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Off-treatment and On-treatment Biochemical Flares | Off-treatment (time period after stopping all study drugs [including NA]) biochemical flare was defined as first date of 2 consecutive visits with ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare) while participant received no study drugs. End date of same off-treatment biochemical flare was defined as first date with 50 percentage (%) reduction from peak ALT and/or AST level & <3*ULN. On-treatment (time period during which the participant received any of study drugs) biochemical flare was defined as first date of 2 consecutive visits with ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare) while participant was on-treatment. End date of same on-treatment biochemical flare was defined as first date with a 50% reduction from the peak ALT and/or AST level and <3*ULN, regardless of stopping study drugs. Participants were counted only once for any given flare, regardless of the number of times they actually experienced flare. | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories and n=0 signifies that no participant was available for the analysis at the specified category. | Posted | | Number | | percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Off-treatment Clinical Flares | Percentage of participants with off-treatment clinical flares were reported. Clinical flares occurred either when a virologic flare and biochemical flare overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. Off-treatment was defined as the time period after stopping all study drugs (including NA). The start date of a clinical flare was the minimum start date of the virologic flare and biochemical flare. The end date of a clinical flare was the maximum end date of the virologic flare and biochemical flare, that is, the later date between HBV DNA returned to <=200 IU/mL (or <=1 log10) and 50 %reduction from the peak ALT and/or AST level and <3*ULN reached during the biochemical flare. Participants were counted only once for any given flare, regardless of the number of times they actually experienced the flare. | ITT population: participants randomly assigned/enrolled to an intervention arm and received at least 1 dose of drug. Participants were analyzed according to study drug randomly assigned/enrolled. "N" (Number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 1, as no participants met off-treatment criteria (set duration between last dose and last study visit) at final analysis and thus were not considered eligible for analysis. | Posted | | Number | | percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Time to First Occurence of HBsAg Seroclearance | Time to first occurrence of HBsAg seroclearance (defined as quantitative HBsAg \ | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. | Posted | | Median | 80% Confidence Interval | weeks | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Virologic Breakthrough | Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as having a confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level < LLOQ (<20 IU/mL) or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level \ | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. | Posted | | Number | 80% Confidence Interval | percentage of participants | | From baseline (Day 1) up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria [NAcc:alanine aminotransferase {ALT} less than {<}3*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} <lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}], HBeAg negative & HB surface antigen {HBsAg} <10 IU/mL] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met in FU, NA was re-started. |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Percentage of participants with TEAES (including serious and non-serious) and TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | | Number | | percentage of participants | | Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses | Number of participants with HBV-specific peripheral blood T-cell responses were reported. HBV-specific T-cells were characterized in peripheral blood mononuclear cell immune analysis by binding assays (multimer staining) combined with downstream T-cell responses and transcriptome profiling. | ITT population were analyzed. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified categories. Here, n=0, signifies that no participants were available for the analysis. | Posted | | Count of Participants | | Participants | | Open-label: Weeks 40, 44, and 48; Follow-up Phase: Follow-up Weeks 2, 12 and 24 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests | Clinical laboratory test parameters were Hematology : absolute neutrophil count (ANC); Chemistry : alanine aminotransferase (ALT) and serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST) or serum glutamic oxaloacetic transaminase (SGOT), amylase (pancreatic and total), creatinine Kinase, creatinine, low-density lipoprotein (LDL), lipase, estimated glomerular filtration rate (eGFR) on serum creatinine (Cr). DAIDS toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Percentage of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure. For toxicity grades, treatment-emergent was concluded if the postbaseline grade was worse than the baseline grade. Only those abnormality categories in which at least one participant had data were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "n" (number analyzed) signifies number of participants analyzed at specified categories. | Posted | | Number | | percentage of participants | | Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High)Treatment-emergent DAIDS Toxicity Grade in Electrocardiogram (ECG) | ECG parameters included ECG mean heart rate (HR)(beats per minute[bpm]), Pulse rate (PR) interval (milliseconds [ms]), QRS duration (ms) and QTc Corrected (Fridericia's formula QTcF). Abnormalities were graded as follows: ECG mean heart rate (abnormally low HR <45 bpm) and (abnormally high HR>=120 bpm); PR interval (abnormally high >220 ms) and QPRS (abnormally high >=120 ms); OT interval corrected for heart rate according to Fridericia (QTcF); borderline prolonged (BRD Pr )QTc (>=450 to <=480 ms), prolonged QTc (>=480 to <=500 ms)and pathologically prolonged QTc (>500 ms). For worst abnormality, treatment-emergent was concluded if the abnormality worsened as compared to the abnormality at baseline: abnormally high to abnormally low and vice-versa. Only those abnormality categories in which at least one participant had data were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High) Treatment-emergent DAIDS Toxicity Grade in Vital Signs | Percentage of participants with worst treatment-emergent DAIDS toxicity grade in vital signs were reported. Abnormality grades were: pulse rate (abnormally low <=45 bpm) and (abnormally high >=120 bpm). An assessment was treatment-emergent if abnormality worsened as compared to the abnormality at baseline: from abnormally high to abnormally low and vice-versa. Only the category (pulse rate) in which at least one participant had data were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 1, 2 and 3: Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Physical Examination | Number of participants with clinically significant treatment-emergent abnormalities in physical examination were reported. Physical examination included head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological examinations. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | | Count of Participants | | Participants | | Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48 | | | | ID | Title | Description |
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| OG000 | OL Phase: Panel 1 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria [ALT <3*ULN, HBV DNA ](streamdown:incomplete-link) |
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| Secondary | Panel 2 and 3: Plasma Trough Concentration (C[0hour]) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Plasma trough concentration (C[0hour]) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. C0h was the pre-dose plasma concentration of the JNJ-73763989 (JNJ-73763976, JNJ-73763924). Non-compartmental analysis were conducted to analyze plasma concentration of JNJ-73763989 and its molecules. | A pharmacokinetics (PK) analysis which included participants of Panel 2 and Panel 3 who had consented to participate in the intensive PK subgroup were analyzed. Data for this outcome measure was planned to be collected and analyzed for Panel 2 and 3 alone. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Week 4 : Pre-dose on Day 29 | | | | ID | Title | Description |
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| OG000 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Secondary | Panel 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Maximum observed plasma concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules. | Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were >=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure. | Posted | | Number | | nanograms per milliliter (ng/mL) | | Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose | | | | ID | Title | Description |
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| OG000 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week] 0 to Week 44 + JNJ-6379 250 mg tablet QD and NA treatment (ETV 0.5 mg, TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48, or JNJ-3989 200 mg SC injection Q4W (from Day 1 [Week 0] to Week 44) + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48. After PA 5, participants discontinued JNJ-6379 but continued treatment with JNJ-3989 + NA (ETV, TD, or TAF). Participants with a separate consent started optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW started after Week 40 liver biopsy for 12 or 24 weeks (till study Week 60 or 72) at investigator's discretion. At Week 48, all participants entered follow-up and stopped all study drugs, but NA was continued till end of follow-up (study Week 96) if NA treatment completion criteria (ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL) was not met at Week 48. Participants who met NA treatment completion criteria (at Week 48) were monitored Q4W in the follow-up phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met, NA retreatment was started. |
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| Secondary | Panel 3: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Maximum observed plasma concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules. | Pharmacokinetics (PK) analysis which included Panel 3 participants who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Secondary | Panel 2 and 3: Minimum Observed Plasma Concentration (Cmin) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Minimum observed plasma concentration (Cmin) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmin of JNJ-73763989 and its molecules | A pharmacokinetics (PK) analysis which included participants of Panel 2 and Panel 3 who had consented to participate in the intensive PK subgroup were analyzed. Data for this outcome measure was planned to be collected and analyzed for Panel 2 and 3 alone. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose | | | | ID | Title | Description |
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| OG000 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Secondary | Panel 2: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976,JNJ-73763924) | Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules. | Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were >=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure. | Posted | | Number | | hours | | Week 4 (Day 29): Post dose (15 minutes, 30 minutes, 1, 2, 3, 4, 6, and 24 hours) | | | | ID | Title | Description |
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| OG000 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week] 0 to Week 44 + JNJ-6379 250 mg tablet QD and NA treatment (ETV 0.5 mg, TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48, or JNJ-3989 200 mg SC injection Q4W (from Day 1 [Week 0] to Week 44) + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48. After PA 5, participants discontinued JNJ-6379 but continued treatment with JNJ-3989 + NA (ETV, TD, or TAF). Participants with a separate consent started optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW started after Week 40 liver biopsy for 12 or 24 weeks (till study Week 60 or 72) at investigator's discretion. At Week 48, all participants entered follow-up and stopped all study drugs, but NA was continued till end of follow-up (study Week 96) if NA treatment completion criteria (ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL) was not met at Week 48. Participants who met NA treatment completion criteria (at Week 48) were monitored Q4W in the follow-up phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met, NA retreatment was started. |
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| Secondary | Panel 3:Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules. | Pharmacokinetics (PK) analysis which included Panel 3 participants who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Median | Full Range | hours | | Week 4 (Day 29): Post dose (15 minutes, 30 minutes, 1, 2, 3, 4, 6, and 24 hours) | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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| Secondary | Panel 2: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze AUC0 to 24h of JNJ-73763989 and its molecules. | Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were >=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure. | Posted | | Number | | nanograms*hour per milliliters (ng*h/mL) | | Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose | | | | ID | Title | Description |
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| OG000 | Panel 2 | Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week] 0 to Week 44 + JNJ-6379 250 mg tablet QD and NA treatment (ETV 0.5 mg, TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48, or JNJ-3989 200 mg SC injection Q4W (from Day 1 [Week 0] to Week 44) + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) tablet QD from Day 1 (Week 0) to Week 48. After PA 5, participants discontinued JNJ-6379 but continued treatment with JNJ-3989 + NA (ETV, TD, or TAF). Participants with a separate consent started optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW started after Week 40 liver biopsy for 12 or 24 weeks (till study Week 60 or 72) at investigator's discretion. At Week 48, all participants entered follow-up and stopped all study drugs, but NA was continued till end of follow-up (study Week 96) if NA treatment completion criteria (ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL) was not met at Week 48. Participants who met NA treatment completion criteria (at Week 48) were monitored Q4W in the follow-up phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL & ALT >5*ULN) was met, NA retreatment was started. |
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| Secondary | Panel 3: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) | Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze AUC0 to 24h of JNJ-73763989 and its molecules. | A pharmacokinetics (PK) analysis which included participants of Panel 3 who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | Posted | | Mean | Standard Deviation | nanograms*hour per milliliters (ng*h/mL) | | Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose | | | | ID | Title | Description |
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| OG000 | Panel 3 | After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria [ALT <3*ULN, HBV DNA <LLOQ; 20 IU/mL, HBeAg negative and HBsAg <10 IU/mL] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA >20,000 IU/mL, HBV DNA >2,000 IU/mL but <20,000 IU/mL and ALT >5*ULN) were met in FU phase, NA retreatment was started. |
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