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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000672-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
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The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Experimental | Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants will receive selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up. Participants will be followed up for 48 weeks post treatment. |
|
| Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Experimental | Viremic participants with CHB will receive VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who meet the criteria to initiate NUC treatment will receive TAF 25, mg orally, QD during the study. Participants will be followed up for 48 weeks post treatment. |
|
| Cohort 2 Group B: SLGN + Nivolumab | Experimental | Viremic participants with CHB will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who meet the criteria to initiate NUC treatment will receive TAF 25 mg orally QD during the study. Participants will be followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Alafenamide | Drug | Administered as film-coated oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Functional Cure | Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off. | At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion | HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. | Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| Royal Melbourne Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wong GL, Lim SG, Agarwal K, Avihingsanon A, Lim Y, et al. Results From a Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Novel Combination Therapies Containing VIR-2218, Selgantolimod, and Nivolumab for the Treatment of Chronic Hepatitis B. Poster #1380; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA. | ||
| Background | Pan D, Kolhatkar N, Sowah L, Arizpe A, Cloutier D, et al. Immunologic Biomarker Dynamics in Chronic Hepatitis B: Insights From a Phase 2a Open-Label Study on Combination Therapies With Small Interfering RNA, Selgantolimod, and Nivolumab. Poster #1134; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA. | ||
| Background | Gane EJ, Tanwandee T, Yi B, Chew T, Botros I, et al. Immune-Related Adverse Events With Low-Dose Nivolumab in Patients With Chronic Hepatitis B: Experience From 3 Clinical Studies. Poster #1332; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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165 participants were screened.
Participants were enrolled at study sites in Australia, Denmark, Hong Kong, New Zealand, Singapore, South Korea, Thailand, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) received tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants also received selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who were on TAF treatment continued TAF treatment over the duration of study follow-up. Participants were followed up for 48 weeks post treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2023 | May 24, 2025 |
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|
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| VIR-2218 | Drug | Administered as a sub-cutaneous (SC) injection |
|
| Nivolumab | Drug | Administered intravenously |
|
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| Selgantolimod | Drug | Administered as film-coated oral tablets |
|
|
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline | HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. | Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72) |
| Percentage of Participants Who Remain Off NUC Treatment During Follow-Up | NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off. | Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72 |
| Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments | Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off. | Up to 36 Weeks |
| Parkville |
| Victoria |
| 3050 |
| Australia |
| Aalborg University Hospital | Aalborg | DK9000 | Denmark |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense University Hospital | Odense | DK5000 | Denmark |
| Princess Margaret Hospital (Hong Kong) | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Alice Ho Miu Ling Nethersole Hospital | Tai Po | Hong Kong |
| Auckland City Hospital | Grafton | 1010 | New Zealand |
| National University Hospital | Singapore | 119228 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul Saint Mary Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Thai Red Cross AIDS Research Centre (HIV-NAT) | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital | Muang | 50200 | Thailand |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| FG001 | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Viremic participants with CHB received VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who met the criteria to initiate NUC treatment received TAF 25, mg orally, QD during the study. Participants were followed up for 48 weeks post treatment. |
| FG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | NUC -suppressed participants with CHB received TAF 25 mg orally QD for 36 weeks and VIR-2218 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who were on TAF treatment continued TAF treatment over the duration of study follow-up. Participants were followed up for 48 weeks post treatment. |
| BG001 | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Viremic participants with CHB received VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who met the criteria to initiate NUC treatment received TAF 25, mg orally, QD during the study. Participants were followed up for 48 weeks post treatment. |
| BG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Functional Cure | Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off. | The Full Analysis Set included all enrolled participants in Cohort 1, or all randomized participants in Cohort 2 who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48) |
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| Secondary | Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion | HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. In Cohort 2 Group B, participants received study treatment for up to 24 weeks. Thereafter, participants were followed up for 48 weeks. Therefore, data for Weeks 28, 32, and 36 are not reported for this cohort in this outcome measure. | Posted | Number | percentage of participants | Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72) |
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| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline | HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. | Participants in the Full Analysis Set with HBeAg positive at Baseline were analyzed. In Cohort 2 Group B, participants received study treatment for up to 24 weeks. Thereafter, participants were followed up for 48 weeks. Therefore, data for Weeks 28, 32, and 36 are not reported for this cohort in this outcome measure. | Posted | Number | percentage of participants | Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72) |
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| Secondary | Percentage of Participants Who Remain Off NUC Treatment During Follow-Up | NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off. | The Follow-Up Analysis Set included all participants who have at least 1 follow-up visit, after completing or premature discontinued from the study drugs. | Posted | Number | percentage of participants | Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72 |
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| Secondary | Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments | Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 36 Weeks |
|
All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks
All-cause Mortality: The All Enrolled Analysis Set included all participants in Cohort 1 who received a study participant identification number in the study after screening, or all participants in Cohort 2 who were randomized in the study.
Adverse events: The Safety Analysis Set includes all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | NUC -suppressed participants with CHB received TAF 25 mg orally QD for 36 weeks and VIR-2218 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who were on TAF treatment continued TAF treatment over the duration of study follow-up for 48 weeks. Participants were followed up for 48 weeks post treatment. | 0 | 42 | 2 | 42 | 34 | 42 |
| EG001 | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Viremic participants with CHB received VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who met the criteria to initiate NUC treatment received TAF 25, mg orally, QD, for up to 36 weeks during the study. Participants were followed up for 48 weeks post treatment. | 0 | 40 | 5 | 40 | 37 | 40 |
| EG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD for up to 36 weeks during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. | 0 | 21 | 3 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chronic hepatitis B | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pseudopapilloedema | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2024 | May 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
| D000077594 | Nivolumab |
| C000712275 | selgantolimod |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
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| South Korea |
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| Singapore |
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| Hong Kong |
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| Denmark |
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| United Kingdom |
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| Thailand |
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| Australia |
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| OG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
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Viremic participants with CHB received VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who met the criteria to initiate NUC treatment received TAF 25, mg orally, QD during the study. Participants were followed up for 48 weeks post treatment. |
| OG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
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| OG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
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| OG002 | Cohort 2 Group B: SLGN + Nivolumab | Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
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