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Trial · NCT04856085

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryProportion of participants with treatment-emergent adverse events (TEAEs)Up to 72 weeks
PrimaryProportion of participants with serious adverse events (SAEs)Up to 72 weeks
PrimaryProportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatmentUp to 48 weeks
PrimaryProportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatmentUp to 72 weeks
SecondaryAbsolute serum HBsAg and change from baseline across all timepoints in the studyUp to 110 weeks
SecondaryNadir and maximum reduction of serum HBsAg from baselineUp to 110 weeks
SecondaryProportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)Up to 110 weeks
SecondaryFor hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepointUp to 110 weeks
SecondaryFor HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversionUp to 110 weeks
SecondaryCmaxUp to 110 weeks
SecondaryAUClastUp to 110 weeks
Secondaryt1/2Up to 110 weeks
SecondaryCL/FUp to 110 weeks
SecondaryNumber of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434Up to 110 weeks
SecondaryProportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuationUp to 60 weeks
SecondaryProportion of participants meeting criteria for NRTI retreatmentUp to 110 weeks
Secondary
Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Up to 110 weeks
SecondaryProportion of participants with serum HBsAg < 10 IU/mL at end of treatmentUp to 48 weeks
SecondaryProportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatmentUp to 72 weeks48 weeks treatment + 24 weeks post-end of treatment
SecondaryProportion of participants with anti-HBs seroconversionUp to 110 weeks

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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