Trial · NCT03439254
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) | Up to 18 months | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 12 months | Safety Population: included all randomized participants who received at least 1 dose of investigational product (OCA or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) | Baseline and up to Month 12 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Kilopascal (kPa) | MEDIAN |
| PRIMARY | OLE Phase: Fibrosis-4 (FIB-4) at Baseline | Baseline (Day 1) | ITT Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| PRIMARY | OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline | Baseline (Day 1) | ITT Population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| PRIMARY | OLE Phase: Number of Participants Reporting All-cause Mortality | Up to Month 12 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Phase: Change From Baseline to Month 18 in LSM | Baseline and up to Month 18 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Kilopascal (kPa) | MEDIAN |
| SECONDARY | DB Phase: FIB-4 at Baseline | Baseline (Day 1) | ITT Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| SECONDARY | DB Phase: ELF at Baseline | Baseline (Day 1) | ITT Population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| PRIMARY | OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death | Up to 12 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score | Up to 12 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Model for End-Stage Liver Disease (MELD) Score ≥15 | Up to 12 months | Safety Population | Participants | COUNT_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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03439254/outcomes