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Trial · NCT06923280

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryHBV DNA and HBsAg undetectable with/without anti-HBsweek 72
Proportion of patients achieving HBV DNA below the lower limit of quantification (LLOQ; \<20 IU/mL), HBsAg undetectable (\<0.05 IU/mL) (with or without anti-HBs seroconversion), and normal liver biochemical indices at Week 72.
SecondaryHBV DNA and HBsAg undetectable with/without anti-HBs during the studyWeeks 24, 48, and 96Proportion of patients achieving HBV DNA \<20 IU/mL, HBsAg \<0.05 IU/mL (with or without anti-HBs), and normal liver biochemistry at Weeks 24, 48, and 96.
SecondaryHBV DNA and HBsAg undetectable during the studyWeeks 24, 48, 72, and 96Proportion of patients achieving HBsAg \<0.05 IU/mL and HBV DNA \<20 IU/mL at Weeks 24, 48, 72, and 96.
SecondaryHBsAg levelWeeks 24, 48, 72, and 96HBsAg levels in each group at Weeks 24, 48, 72, and 96
SecondaryHBsAg decline from baselineWeeks 24, 48, 72, and 96Magnitude of HBsAg decline from baseline in each group at Weeks 24, 48, 72, and 96
SecondaryHBsAg seroclearanceWeeks 24, 48, 72, and 96HBsAg seroclearance rate (HBsAg \<0.05 IU/mL) in each group at Weeks 24, 48, 72, and 96
SecondaryHBsAg seroconversionWeeks 24, 48, 72, and 96HBsAg seroconversion rate (anti-HBs ≥10 mIU/mL) in each group at Weeks 24, 48, 72, and 96
SecondaryHBeAg seroclearanceWeeks 24, 48, 72, and 96HBeAg seroclearance rate in baseline HBeAg-positive patients at Weeks 24, 48, 72, and 96
SecondaryHBeAg seroconversionWeeks 24, 48, 72, and 96HBeAg seroconversion rate (anti-HBe positivity) in baseline HBeAg-positive patients at Weeks 24, 48, 72, and 96
SecondaryHBV DNA levelWeeks 24, 48, 72, and 96HBV DNA levels in each group at Weeks 24, 48, 72, and 96
SecondaryHBV DNA decline from baselineWeeks 24, 48, 72, and 96Magnitude of HBV DNA decline from baseline in each group at Weeks 24, 48, 72, and 96
SecondaryHBV DNA undetectabeWeeks 24, 48, 72, and 96HBV DNA undetectability rate (\<20 IU/mL) in baseline HBV DNA-positive patients at Weeks 24, 48, 72, and 96
SecondaryALT levelsWeeks 24, 48, 72, and 96ALT levels in each group at Weeks 24, 48, 72, and 96
SecondaryALT normalizationWeeks 24, 48, 72, and 96ALT normalization rate (≤upper limit of normal \[ULN\]) in each group at Weeks 24, 48, 72, and 96
SecondaryALT levels from baselineWeeks 24, 48, 72, and 96Change in ALT levels from baseline in each group at Weeks 24, 48, 72, and 96
SecondarysafteyWeeks 24, 48, 72, and 96
Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) during the study, including findings from Physical examinations, Laboratory tests, Hematology, Urinalysis, Blood biochemistry, Coagulation profile
SecondaryPercentage of patients who achieved functional cure24 weeks off Peg-IFNα treatmentsustained undetectable HBV DNA and HBsAg loss for at least 24 weeks off Peg-IFNα treatment
OtherHBV RNAWeeks 24, 48, 72, and 96HBV pregenomic RNA (pgRNA) levels in each group at Weeks 24, 48, 72, and 96.
OtherHBcrAgWeeks 24, 48, 72, and 96HBV core-related antigen (HBcrAg) levels in each group at Weeks 24, 48, 72, and 96
OtherHBsAg-specific T-cell and B-cellduring the studyLongitudinal changes in HBsAg-specific T-cell and B-cell responses during 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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