Trial · NCT04676724
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
| 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) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
| 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) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| 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) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| 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) | Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off. |
| 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) | Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off. |
| 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) | The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. |
| 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) | The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. |
| 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) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive 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) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive 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) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| 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) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| 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) | Blood samples were collected from participants to assess HBsAg at indicated time points. |
| 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) | Blood samples were collected from participants to assess HBsAg at indicated time points. |
| 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) | Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| 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) | Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| 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) | Blood samples were collected to assess HBV DNA levels. |
| 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) | Blood samples were collected to assess HBV DNA levels. |
| 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) | Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| 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) | Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04676724/registered