Trial · NCT03439254
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 45
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) | DB: Placebo | 31 | Participants | ||
| DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) | DB: OCA 10 Milligrams (mg) | 33 | Participants | ||
| DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) | DB: OCA 10 mg Titrated to OCA 25 mg | 37 | Participants | ||
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: OCA 10 mg (DB Placebo) | AEs | 199 | Participants | |
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: OCA 10 mg (DB OCA 10 mg) | AEs | 213 | Participants | |
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | AEs | 197 | Participants | |
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: OCA 10 mg (DB Placebo) | SAEs | 26 | Participants | |
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: OCA 10 mg (DB OCA 10 mg) | SAEs | 50 | Participants | |
| OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | SAEs | 48 | Participants | |
| OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) | OLE: OCA 10 mg (DB Placebo) | -2.10 | Inter-Quartile Range -7.40 to 3.40 | Kilopascal (kPa) | |
| OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) | OLE: OCA 10 mg (DB OCA 10 mg) | -2.90 | Inter-Quartile Range -7.75 to 1.35 | Kilopascal (kPa) | |
| OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) | OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | -3.45 | Inter-Quartile Range -7.85 to 0.75 | Kilopascal (kPa) | |
| OLE Phase: Fibrosis-4 (FIB-4) at Baseline | OLE: OCA 10 mg (DB Placebo) | 2.179 | Standard Deviation 1.0342 | Ratio | |
| OLE Phase: Fibrosis-4 (FIB-4) at Baseline | OLE: OCA 10 mg (DB OCA 10 mg) | 2.267 | Standard Deviation 0.9567 | Ratio | |
| OLE Phase: Fibrosis-4 (FIB-4) at Baseline | OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | 2.266 | Standard Deviation 1.0867 | Ratio | |
| OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline | OLE: OCA 10 mg (DB Placebo) | 10.46 | Standard Deviation 0.933 | Scores on a scale | |
| OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline | OLE: OCA 10 mg (DB OCA 10 mg) | 10.50 | Standard Deviation 0.940 | Scores on a scale | |
| OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline | OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | 10.48 | Standard Deviation 0.821 | Scores on a scale | |
| OLE Phase: Number of Participants Reporting All-cause Mortality | OLE: OCA 10 mg (DB Placebo) | 1 | Participants | ||
| OLE Phase: Number of Participants Reporting All-cause Mortality | OLE: OCA 10 mg (DB OCA 10 mg) | 0 | 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.
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GET https://conductscience.org/api/trials/v1/NCT03439254/results