Trial · NCT04667104
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24 | From Baseline (Day 1) to Week 24 | Full Analysis Set (FAS) included all participants who were enrolled and who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Data for this outcome measure was planned to be collected and analyzed for specified arm only. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this endpoint and n(number analyzed) signifies number of participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was planned to be collected and analyzed at TP 1 and TP 2 for participants with diabetes/hypertension only. Since no subject had diabetes/hypertension hence data for this OM was not collected and analyzed as pre-specified in protocol. | ||
| SECONDARY | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) | At Week 24 (EOSI) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was not planned to be collected and analyzed for Treatment Period 1 and Follow-Up period as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Seroconversion | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Seroconversion | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline Over Time in HBsAg Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. | log10 IU/mL | MEAN |
| SECONDARY | Change From Baseline Over Time in HBeAg Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | log10 IU/mL | MEAN |
| SECONDARY | Change From Baseline Over Time in HBV DNA Levels | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. | log10 IU/mL | MEAN |
| SECONDARY | Time to First Occurrence of HBsAg Seroclearance | From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analyzed in a single arm. | weeks | MEDIAN |
| SECONDARY | Time to First Occurrence of HBeAg Seroclearance | From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed in a single arm. | weeks | 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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