Trial · NCT02308111
Outcomes136
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 136
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Occurrence of Composite Endpoint | Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years) | The Intent-to-Treat (ITT) population included all randomized participants who received any dosage of OCA or placebo. | days | NUMBER |
| PRIMARY | Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint) | Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | days | NUMBER |
| SECONDARY | Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint | Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | days | NUMBER |
| SECONDARY | Time To Liver Transplant Or Death (All-cause) | Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | days | NUMBER |
| SECONDARY | Time to First Occurrence of Fatal Event (All-Cause) | Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | days | NUMBER |
| SECONDARY | Time to First Occurrence of Liver Transplant | Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time to First Occurrence of Hospitalization Due to Hepatic Events | Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time to First Occurrence of Uncontrolled or Refractory Ascites | Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time to First Occurrence of MELD Score ≥15 | Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time To Development Of Varix/Varices | Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time To Liver-Related Death | Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time To Liver-Related Death Or Liver Transplant | Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15 | Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline) | Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Time To Occurrence Of Hepatocellular Carcinoma (HCC) | Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years) | The ITT population included all randomized participants who received any dosage of OCA or placebo. | proportion of participants | NUMBER |
| SECONDARY | Change From Baseline To Month 24 Of Total Bilirubin | Baseline up to Month 24 | The ITT population included all randomized participants who received any dosage of OCA or placebo. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Month 24 Of Direct Bilirubin | Baseline up to Month 24 | The ITT population included all randomized participants who received any dosage of OCA or placebo. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST) | Baseline up to Month 24 | The ITT population included all randomized participants who received any dosage of OCA or placebo. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT) | Baseline up to Month 24 | The ITT population included all randomized participants who received any dosage of OCA or placebo. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP) | Baseline up to Month 24 | The ITT population included all randomized participants who received any dosage of OCA or placebo. | U/L | LEAST_SQUARES_MEAN |
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/NCT02308111/outcomes