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Trial · NCT02138253

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score24 monthsThe Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study drug.participantsNUMBER
SECONDARYNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)24 monthsFull analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score12 monthsFull analysis set, the # of subject analyzed included subjects with an observed Ishak Fibrosis Score at 12 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAlanine Aminotransferase (ALT) - Change From BaselineBaseline and 24 monthsFull analysis set, the # of subject analyzed included subjects with an observed ALT at 24 months.U/LMEAN
SECONDARYAspartate Aminotransferase (AST) Change From BaselineBaseline and 24 monthsFull analysis set, the # of subject analyzed included subjects with an observed AST at 24 months.U/LMEAN
SECONDARYCaspase 3/7 Change From BaselineBaseline and 24 monthsFull analysis set, the # of subject analyzed included subjects with an observed Caspase 3/7 at 24 months.Raw RLUMEAN
SECONDARYcCK18/M30 Change From BaselineBaseline and 24 monthsFull analysis set, the # of subject analyzed included subjects with an observed cCK18/M30 at 24 months.U/LMEAN
SECONDARYflCK18/M65 Change From BaselineBaseline and 24 monthsFull analysis set, the # of subject analyzed included subjects with an observed flCK18/M65 at 24 months.U/LMEAN
SECONDARYIshak Modification of Knodell Histological Activity Index - Interface Hepatitis24 monthsFull analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYIshak Modification of Knodell Histological Index - Confluent Necrosis24 monthsFull analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYIshak Modification of Knodell Histological Index - Parenchymal Injury24 monthsFull analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYIshak Modification of Knodell Histological Index - Portal Inflammation24 monthsFull analysis setParticipantsCOUNT_OF_PARTICIPANTS

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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