Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03633227) enrolled 22 children and young people in total — 12 in the placebo group and 10 in the obeticholic acid (OCA) group — during the first phase of the study, which ran up to 48 weeks. The trial was primarily measuring how the body absorbed and processed OCA, a medicine being investigated for a liver condition. Specifically, researchers tracked how much of the drug reached the bloodstream, how quickly it peaked, and how long it stayed in the body. Relatively few participants completed the full double-blind phase (4 in the placebo group and 6 in the OCA group), and none completed the longer extension phase that was intended to run up to three years. The reported data shows results mainly for participants taking OCA at a dose of 5 mg once weekly. At week 12, the peak amount of the drug measured in the blood (called Cmax) was reported as 293 nanograms per millilitre, and the time it took to reach that peak (Tmax) was about 2 hours. The lowest level measured in the blood over a 24-hour period (Ctrough) was 77.6 nanograms per millilitre, and the total exposure to the drug over 24 hours (a measure called AUC) was 2,970 nanogram-hours per millilitre. By week 18, figures were also available for a twice-weekly 5 mg dose group: the peak blood level was 136 ng/mL for the once-weekly group and 406 ng/mL for the twice-weekly group, with peak times of 0.75 hours and 2.52 hours respectively. No data were reported for the 10 mg twice-weekly dose group at either time point, and the results data did not include figures for the placebo group for these measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 19554543) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Primary Biliary Cholangitis Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: abnormal liver enzyme (ALP) levels for 6+ months, a positive blood antibody test linked to PBC, or a liver biopsy showing PBC.
- You have cirrhosis (scarring of the liver), confirmed by at least one of the following: a liver biopsy showing advanced scarring, a liver stiffness test result above a certain level, visible signs of cirrhosis such as swollen veins in the food pipe/stomach, fluid in the abdomen, or imaging showing cirrhosis, or a combination of low platelet count plus other abnormal blood test results.
- Your liver disease is rated as "moderate" or "severe" based on a standard scoring system called Child-Pugh — specifically a score between 7 and 12.
- Your liver disease score on another standard scale (called MELD) is between 6 and 24.
- You have been taking a medication called ursodeoxycholic acid (UDCA) for at least 12 months at a stable dose, OR you have not been able to tolerate it or it has not worked for you (and you have been off it for at least 3 months).
Who may not be able to join:
- You do not have cirrhosis, or your cirrhosis is rated as "mild" on the Child-Pugh scoring system (score of 5 or 6).
- You have previously had a liver transplant or any other organ transplant.
- You have had issues with alcohol or drug misuse in the past 12 months.
- You have moderate to severe confusion or mental symptoms caused by liver disease (a condition called hepatic encephalopathy, scored 2 or above on a standard scale).
- You have another liver condition at the same time, such as active Hepatitis C, active Hepatitis B, primary sclerosing cholangitis, alcoholic liver disease, autoimmune liver disease, overlap hepatitis, or Gilbert's Syndrome.
- In the doctor's opinion, your liver function is unstable or getting worse quickly before the start of the trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Steven Shiff, M.D., Intercept Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Maximum Observed Concentration (Cmax) of Total OCA at Week 12; Time to Maximum Concentration (Tmax) of Total OCA at Week 12; Trough Concentration (Ctrough) of Total OCA at Week 12; Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12; Cmax of Total OCA at Week 18; Tmax of Total OCA at Week 18; Ctrough of Total OCA at Week 18; AUC0-24h of Total OCA at Week 18; Cmax of Total OCA at Week 24; Tmax of Total OCA at Week 24; Ctrough of Total OCA at Week 24; AUC0-24h of Total OCA at Week 24; Cmax of Total OCA at Week 30; Tmax of Total OCA at Week...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.