Trial · NCT04667104
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24. |
| 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) | Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. |
| 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) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| 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) | Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure \[systolic and diastolic\]) were reported. |
| 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) | Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below. |
| 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 | Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) were reported. |
| 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 | Number of participants with clinically significant abnormalities in physical examination were reported. |
| 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 | Number of participants with abnormalities in Ophthalmic examination were planned to be reported. |
| 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) | Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) \<3\*ULN. |
| 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) | Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:\< 100 IU/mL, \< 10 IU/mL, \< 1 IU/mL, \< LLOQ (0.11 IU/mL). |
| 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) | Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<1000 IU/mL, \<100 IU/mL, \<10 IU/mL, \<1 IU/mL, \<LLOQ (0.05 IU/mL). |
| 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) | Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (=20 IU/mL) target detected or not detected, \< LLOQ target not detected, and \< LLOQ target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL. |
| 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) | Percentage of participants with ALT levels below \>=3\*ULN cut-off were reported. |
| 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) | Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (as HBeAg level \<LLOQ \[0.11 IU/mL\]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result. |
| 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) | Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as HBsAg \<LLOQ \[0.05 IU/mL\]) and appearance of anti-HBs antibodies. |
| 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) | Change from baseline over time in HBsAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
| 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) | Change from baseline over time in HBeAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
| 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) | Change from baseline over time in HBV DNA levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. |
| 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) | Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of first occurrence of the HBsAg seroclearance. |
| 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) | Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance. |
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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