Trial · NCT04449029
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Sustained Virologic Response (SVR) | Up to Week 48 | The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving HBsAg and HBV DNA<LLOQ | Up to Week 26 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Changes From Baseline in HBsAg Values | At Baseline and Week 24 | The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Changes From Baseline in HBV DNA Values | At Baseline and Week 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Alanine Aminotransferase (ALT) Normalization | At Baseline and Week 24 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to ALT Normalization | Baseline and up to Week 48 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. Only those participants with baseline ALT\>ULN were analyzed. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb) | Up to Week 48 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | Log10 (IU/mL) | MEAN |
| SECONDARY | Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level | At Baseline, Week 12, and 24 | The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Log10 unit per milliliter (U/mL) | MEAN |
| SECONDARY | Mean Change From Baseline in HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | log IU/mL | MEAN |
| SECONDARY | Mean Change From Baseline in HBeAg Level | At Baseline, Week 12, and 24 | The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Log u/mL | MEAN |
| SECONDARY | Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level | At Baseline, Week 36, and 48 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data. | Log10 IU/mL | MEAN |
| SECONDARY | Mean Change From Baseline in Anti-HBsAg Level | At Baseline, Week 12, and 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data. | Log10 IU/mL | MEAN |
| SECONDARY | Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836 | Up to Week 24 | The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | hour*micrograms per milliliter (h*ug/mL) | MEAN |
| SECONDARY | Mean Maximum Observed Concentration (Cmax) of GSK3228836 | Up to Week 24 | The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | ug/mL | MEAN |
| SECONDARY | Median Time of Maximum Observed Concentration (Tmax) of GSK3228836 | Up to Week 24 | The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | hour | MEDIAN |
| SECONDARY | Mean AUC0-24h of NA Therapies | Up to Week 24 | The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | h*nanograms per milliliter (h*ng/mL) | MEAN |
| SECONDARY | Mean Ctau of NA Therapies | Up to Week 24 | The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | ng/mL | MEAN |
| SECONDARY | Mean Cmax of NA Therapies | Up to Week 24 | The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | ng/mL | MEAN |
| SECONDARY | Median Tmax of NA Therapies | Up to Week 24 | The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | hour | MEDIAN |
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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