Trial · NCT04449029
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Sustained Virologic Response (SVR) | Up to Week 48 | The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. |
| Secondary | Number of Participants Achieving HBsAg and HBV DNA<LLOQ | Up to Week 26 | Participants achieving HBsAg and HBV DNA levels \<LLOQ at the end of treatment (EOT) were reported. |
| Secondary | Number of Participants With Categorical Changes From Baseline in HBsAg Values | At Baseline and Week 24 | 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). |
| Secondary | Number of Participants With Categorical Changes From Baseline in HBV DNA Values | At Baseline and Week 24 | Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of \<1, \>=1, \>=2, and \>=3 log IU/mL. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization | At Baseline and Week 24 | The ALT normalization (ALT≤ upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN. Participants who achieved ALT normalization were reported. |
| Secondary | Median Time to ALT Normalization | Baseline and up to Week 48 | Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT\>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT \>ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively. |
| Secondary | Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb) | Up to Week 48 | Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported. |
| Secondary | Mean HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. |
| Secondary | Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL). |
| Secondary | Mean Change From Baseline in HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL). |
| Secondary | Mean Change From Baseline in HBeAg Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL). |
| Secondary | Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level | At Baseline, Week 36, and 48 | Blood samples were collected to assess anti-HBsAg level at indicated timepoints. |
| Secondary | Mean Change From Baseline in Anti-HBsAg Level | At Baseline, Week 12, and 24 | Blood samples were collected to assess anti-HBsAg level at indicated timepoints. |
| Secondary | Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836 | Up to Week 24 | Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836. |
| Secondary | Mean Maximum Observed Concentration (Cmax) of GSK3228836 | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836. |
| Secondary | Median Time of Maximum Observed Concentration (Tmax) of GSK3228836 | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836. |
| Secondary | Mean AUC0-24h of NA Therapies | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily. |
| Secondary | Mean Ctau of NA Therapies | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily. |
| Secondary | Mean Cmax of NA Therapies | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily. |
| Secondary | Median Tmax of NA Therapies | Up to Week 24 | Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily. |
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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