Trial · NCT04676724
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. | Percentage of Participants | NUMBER |
| PRIMARY | Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 36 to 60) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. The n represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. The n represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 1: Actual Values of HBsAg Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 2: Actual Values of HBsAg Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 1: Actual Values of HBV DNA Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 2: Actual Values of HBV DNA Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
| SECONDARY | Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Log10 IU/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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