Trial · NCT05005507
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI]) | Week 24 | Full analysis set (FAS) included all participants who were randomly assigned to an intervention arm in the intervention-specific appendix (ISA) and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events (SAEs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Vital Signs | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Ophthalmologic Examination | Weeks 8 and 20 | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Abnormalities in Physical Examination | Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up Week 2 Visits | Week 24 (EOSI) and follow-up Week 2 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With HBsAg Seroclearance at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment | Follow-up Weeks 24 and 48 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < (Less Than) LLOQ at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment | Follow-up Weeks 24 and 48 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Virologic Flares | Up to 1 month 26 days | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Biochemical Flares | Up to 1 month 26 days | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Nucleos(t)Ide Analog (NA) Re-treatment | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With HBsAg Seroconversion | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Change From Baseline in HBsAg Over Time | Baseline up to Week 72 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Time to Achieve HBsAg Seroclearance | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Time to Achieve HBsAg Seroconversion | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Time to Achieve HBV DNA <Lower Limit of Quantitation (LLOQ) | Up to 72 weeks | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. |
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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