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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000977-31 | EudraCT Number |
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This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peg-IFN-Alfa-2A + Lamivudine or Entecavir | Experimental | Participants will receive lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks. |
|
| Untreated Control Participants | No Intervention | Untreated control participants will be observed up to 80 weeks. | |
| Peg-INF-Alfa-2A Monotherapy | Experimental | Participants will receive Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation | This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group. | 24 weeks post-treatment/at the end of untreated observation (Week 80) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of HBsAg | This endpoint is defined as loss of HBsAg at 1 year post-treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hosp Clinics | Kansas City | Missouri | 64108 | United States | ||
| Columbia University |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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The study began as a single-site, three arm IST and was subsequently adapted as a multi-center, two arm study, conducted at 22 sites in Malaysia, Taiwan, Australia, Belgium, Germany, United Kingdom, Italy, Romania, Russian Federation, Turkey, Ukraine and the U.S. Enrolment was stopped prematurely, at which time 62 participants had been enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peg-IFN-Alfa-2A + Lamivudine or Entecavir | Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks. |
| FG001 | Untreated Control Participants |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 |
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| Lamivudine | Drug | Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg). |
|
| Pegylated Interferon Alfa-2A | Drug | Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m^2) BSA. |
|
|
This endpoint is defined as loss of HBeAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. |
| 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs | This endpoint measures the seroconversion to anti-HBs defined as loss of HBsAg and presence of anti-HBs at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe | This endpoint measures the seroconversion to anti-HBe defined as loss of HBeAg and presence of anti-HBe at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA) | This endpoint measures different HBV DNA levels (<20000 IU/mL, <2000 IU/mL and undetectable) measured by PCR or hybridization at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-treatment in the treated group. HBV-DNA undetectable is defined as <29 IU/mL. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Change From Baseline in HBV DNA Levels in the Peg-INF-Alfa-2A (Treated) Arm | This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Peg-INF-Alfa-2A + Lamivudine or Entecavir arm. | Baseline, Week 8, 20, 32, 44, 56, Follow up Week 4 and 24 |
| Change From Baseline in HBV DNA Levels in the Untreated Control Participants | This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Untreated Control arm. | Baseline, Week 32, 56 and end of untreated observation (Week 80) |
| Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL | This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <20,000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL | This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <2000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 24 weeks post-treatment/end of untreated observation (Week 80) |
| Percentage of Participants With AEs Leading to Dose Modification or Interruption | This endpoint measures AEs and lab abnormalities leading to dose interruption or dose modification. Does modification included dose reduced, dose increased or drug interrupted. Adverse events included laboratory abnormalities reported as adverse events. | Baseline up to 24 weeks post-end of treatment |
| Serum Concentration of Peg-INF-Alfa-2A | The serum concentration of Peg-INF-Alfa-2A was measured in picogram/milliliter. | At Weeks 12, 16, 20, 32, 44, 56 |
| New York |
| New York |
| 10032-3725 |
| United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Womens and Childrens Hospital; Department of Gastroenterology | North Adelaide | South Australia | 5006 | Australia |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II | Essen | 45122 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin | Mainz | 55131 | Germany |
| Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik | München | 80337 | Germany |
| HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke | Wuppertal | 42283 | Germany |
| Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive | Bologna | Emilia-Romagna | 40138 | Italy |
| University Malaya Medical Center; Department of Paediatrics | Kuala Lumpur | 59100 | Malaysia |
| Grigore Alexandrescu Emergency Clinical Hospital for Children | Bucharest | 011743 | Romania |
| FSI Scientific research Institute of children's infections | Saint Petersburg | 197022 | Russia |
| MC Gepatolog | Samara | 443100 | Russia |
| Chang-Gung Memorial Hospital-Linkou; Division of Pediatric Gastroenterology, Dept Pediatrics | Taoyuan County | 333 | Taiwan |
| Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases | Adana | 01330 | Turkey (Türkiye) |
| Ankara University School of Medicine, Pediatrics Department; Pediatric Gastroenterology | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Uni , School of Medicine; Gastroenterology | Ankara | 06100 | Turkey (Türkiye) |
| Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji | Ankara | 06500 | Turkey (Türkiye) |
| SI Institute of the pediatrics, obstetrics and gynecology | Kyiv | 04050 | Ukraine |
| Birmingham Children'S Hopsital; Liver Unit | Birmingham | B4 6NH | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7AU | United Kingdom |
| Kings College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| North Manchester General Hospital | Manchester | M8 5RB | United Kingdom |
Untreated control participants were observed up to 80 weeks.
| FG002 | Peg-INF-Alfa-2A Monotherapy | Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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|
Due to the low participant number (n=3) in the Peg-INF-Alfa-2A Monotherapy arm, data is not presented in this summary for this arm to avoid participant re-identification as well as in consideration of any summary statistics would be misleading, therefore the three participants were presented in listings in the study report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peg-IFN-Alfa-2A + Lamivudine or Entecavir | Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks. |
| BG001 | Untreated Control Participants | Untreated control participants were observed up to 80 weeks. |
| BG002 | Peg-INF-Alfa-2A Monotherapy | Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Due to the low participant number (n=3) in the Peg-INF-Alfa-2A Monotherapy arm, data is not presented in this summary for this arm in consideration to avoid participant re-identification. | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Due to the low participant number (n=3) in the Peg-INF-Alfa-2A Monotherapy arm, data is not presented in this summary for this arm in consideration to avoid participant re-identification. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Due to the low participant number (n=3) in the Peg-INF-Alfa-2A Monotherapy arm, data is not presented in this summary for this arm in consideration to avoid participant re-identification. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Due to the low participant number (n=3) in the Peg-INF-Alfa-2A Monotherapy arm, data is not presented in this summary for this arm in consideration to avoid participant re-identification. | Count of Participants | 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 With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation | This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group. | The Intent to treat (ITT) population was defined as all participants who received at least one dose of study medication of treated group. For untreated group, the ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment/at the end of untreated observation (Week 80) |
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| Secondary | Percentage of Participants With Loss of HBsAg | This endpoint is defined as loss of HBsAg at 1 year post-treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | The analysis population included participants from the Peg-INF-Alfa-2A arm, who received at least one dose of study medication of treated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated participants). | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg) | This endpoint is defined as loss of HBeAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs | This endpoint measures the seroconversion to anti-HBs defined as loss of HBsAg and presence of anti-HBs at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe | This endpoint measures the seroconversion to anti-HBe defined as loss of HBeAg and presence of anti-HBe at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA) | This endpoint measures different HBV DNA levels (<20000 IU/mL, <2000 IU/mL and undetectable) measured by PCR or hybridization at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-treatment in the treated group. HBV-DNA undetectable is defined as <29 IU/mL. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Change From Baseline in HBV DNA Levels in the Peg-INF-Alfa-2A (Treated) Arm | This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Peg-INF-Alfa-2A + Lamivudine or Entecavir arm. | The analysis population included participants from the Peg-INF-Alfa-2A arm, who received at least one dose of study medication of treated group. Only participants for whom data were collected are included in the analysis. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 8, 20, 32, 44, 56, Follow up Week 4 and 24 |
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| Secondary | Change From Baseline in HBV DNA Levels in the Untreated Control Participants | This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Untreated Control arm. | The analysis population included participants from the Untreated Control arm. Only participants for whom data were collected are included in the analysis. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 32, 56 and end of untreated observation (Week 80) |
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| Secondary | Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL | This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <20,000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL | This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <2000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. | All participants who received at least one dose of study medication of treated group, and all randomized participants in the untreated group. None of the participants from the untreated group were assessed at 1 year post-end of treatment as they were only observed up to 80 weeks (=24 weeks post-treatment for treated group) | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56) |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population included all participants who received at least one dose of study medication and had at least one post-baseline safety assessment. For untreated group, the safety population included all randomized participants who had at least one post-baseline safety assessment. | Posted | Number | Percentage of Participants | Baseline up to 24 weeks post-treatment/end of untreated observation (Week 80) |
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| Secondary | Percentage of Participants With AEs Leading to Dose Modification or Interruption | This endpoint measures AEs and lab abnormalities leading to dose interruption or dose modification. Does modification included dose reduced, dose increased or drug interrupted. Adverse events included laboratory abnormalities reported as adverse events. | The safety analysis population included all participants who received at least one dose of study medication and had at least one post-baseline safety assessment in the Peg-INF-Alfa-2A treated arm. | Posted | Number | Percentage of Participants | Baseline up to 24 weeks post-end of treatment |
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| Secondary | Serum Concentration of Peg-INF-Alfa-2A | The serum concentration of Peg-INF-Alfa-2A was measured in picogram/milliliter. | The analysis population was the Peg-IFN-Alfa-2A + Lamivudine or Entecavir arm. The untreated arm did not receive any study medication. Only participants for whom data were collected are included in the analysis. | Posted | Mean | Standard Deviation | pg/mL | At Weeks 12, 16, 20, 32, 44, 56 |
|
|
From Baseline up to 1 year post-end of treatment in the treated arm; From Baseline to end of untreated observation (Week 80) in the untreated group [up to clinical cut-off date 29 Jan 2020]
The safety population included all participants who received at least one dose of study medication and had at least one post-baseline safety assessment. For untreated group, the safety population included all randomized participants who had at least one post-baseline safety assessment. Total # at Risk =0 in Other (Not Including Serious) Adverse Events section represents not reported data in consideration of participant re-identification.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peg-IFN-Alfa-2A + Lamivudine or Entecavir | Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks. | 0 | 26 | 0 | 26 | 21 | 26 |
| EG001 | Untreated Control Participants | Untreated control participants were observed up to 80 weeks. | 0 | 33 | 1 | 33 | 10 | 33 |
| EG002 | Peg-INF-Alfa-2A Monotherapy | Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks. | 0 | 3 | 0 | 3 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 22.1 | Systematic Assessment |
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| HYPERTHERMIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| INJECTION SITE BRUISING | General disorders | MedDRA 22.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 22.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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In accordance with the recommendation from the DSMB, enrollment was stopped due to low efficacy and a changed benefit risk assessment. Enrolled participants were allowed to complete treatment and were followed up for 1 year after the end of treatment
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Jul 15, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C413685 | entecavir |
| D019259 | Lamivudine |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
Not provided
Not provided
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