Trial · NCT05005507
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Percentage of participants with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were planned to be reported. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to 1 month 26 days | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | Up to 1 month 26 days | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Secondary | Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Up to 1 month 26 days | Percentage of participants with abnormalities in clinical laboratory tests including hematology, blood coagulation, blood biochemistry, urinalysis, urine chemistry, renal biomarkers, were reported. |
| Secondary | Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs) | Up to 1 month 26 days | Percentage of participants with abnormalities in 12-Lead ECGs were reported. |
| Secondary | Percentage of Participants With Abnormalities in Vital Signs | Up to 1 month 26 days | Percentage of participants with abnormalities in vital signs were reported. |
| Secondary | Percentage of Participants With Abnormalities in Ophthalmologic Examination | Weeks 8 and 20 | Percentage of participants with abnormalities in ophthalmologic examination were planned to be reported. |
| Secondary | Percentage of Participants With Abnormalities in Physical Examination | Week 24 | Percentage of participants with abnormalities in physical examination were planned to be reported. |
| 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 | Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or follow-up Week 2 visits was planned to be reported. NA treatment completion criteria were as follows: (a) participant had alanine transaminase (ALT) \<3\*upper limits of normal (ULN); (b) participant had Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) \<20 international units per milliliter (IU/mL); (c) participant was Hepatitis B e antigen (HBeAg)-negative; (d) participant had Hepatitis B surface antigen (HBsAg\<10 IU/mL. |
| 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 | Percentage of participants with HBsAg seroclearance at follow-up Weeks 24 and 48 without re-starting NA treatment were planned to be reported. Seroclearance of HBsAg is defined as a (quantitative) HBsAg level \<lower limit of quantitation (LLOQ). LLOQ is 0.05 International Units per milliliter (IU/mL). |
| 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 | Percentage of participants with HBV DNA \<LLOQ at follow-up Weeks 24 and 48 without re-starting NA treatment were planned to be reported. LLOQ is 0.05 IU/mL. |
| Secondary | Percentage of Participants With Virologic Flares | Up to 1 month 26 days | Percentage of participants with virologic flares were reported. The start of a confirmed virologic flare is defined as the first date of two consecutive visits with HBV DNA \>200 IU/mL. The end date of the same confirmed virologic flare is defined as the first date when HBV DNA value returns to less than or equal to (\<=)200 IU/mL or the date of NA treatment restart, whichever comes first. |
| Secondary | Percentage of Participants With Biochemical Flares | Up to 1 month 26 days | Percentage of participants with biochemical flares were reported. The start date of a confirmed off-treatment biochemical flare: the first date of two consecutive visits with ALT and/or AST\>=3x ULN and \>=3x off-treatment/on-treatment nadir (that is, lowest value observed during off-treatment period up to the time point of meeting the biochemical flare criteria) while the participant does not receive any of the study interventions. The end date of the same off-treatment/on-treatment biochemical flare: the first date when there is a 50% reduction from the peak ALT and/or AST level \& \<3x ULN. |
| Secondary | Percentage of Participants Requiring Nucleos(t)Ide Analog (NA) Re-treatment | Up to 72 weeks | Percentage of participants requiring NA re-treatment were planned to be reported. |
| 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 | Percentage of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs were planned to be reported. |
| Secondary | Percentage of Participants With HBsAg Seroconversion | Up to 72 weeks | Percentage of participants with HBsAg seroconversion were planned to be reported. Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (quantitative HBsAg level \<LLOQ) and appearance of anti-HBs antibodies. LLOQ is 0.05 IU/mL. |
| Secondary | Change From Baseline in HBsAg Over Time | Baseline up to Week 72 | Change from baseline in HBsAg over time were planned to be reported. |
| Secondary | Time to Achieve HBsAg Seroclearance | Up to 72 weeks | Time to achieve HBsAg seroclearance were planned to be reported. Time to achieve HBsAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance (that is, the date of the first HBsAg seroclearance - the date of first study intervention intake + 1). Seroclearance of HBsAg is defined as a (quantitative) HBsAg level \<LLOQ. LLOQ is 0.05 IU/mL. |
| Secondary | Time to Achieve HBsAg Seroconversion | Up to 72 weeks | Time to achieve HBsAg seroconversion were planned to be reported. Time to achieve HBsAg seroconversion is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance and appearance of anti-HBs antibodies (that is, the date of the first HBsAg seroclearance and anti-HBs antibodies - the date of first study intervention intake + 1). Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (quantitative HBsAg level \<LLOQ) and appearance of anti-HBs antibodies. LLOQ is 0.05 IU/mL. |
| Secondary | Time to Achieve HBV DNA <Lower Limit of Quantitation (LLOQ) | Up to 72 weeks | Time to achieve HBV DNA \<LLOQ were planned to be reported. Time to achieve HBV DNA \<LLOQ is defined as the number of days between HBV DNA \>LLOQ for participants who re-treated with NA and the date of the first occurrence of HBV DNA \< LLOQ after NA re-treatment (that is, the date of the HBV DNA \< LLOQ after being re-treated with NA - the date of first occurrence of HBV DNA\>LLOQ + 1). LLOQ is 0.05 IU/mL. |
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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