Phase 2 Primary Biliary Cholangitis Trial, Terminated (NCT00550862)

Phase 2 Primary Biliary Cholangitis Trial, Terminated NCT00550862 Sponsor: Intercept Pharmaceuticals Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT00550862 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Primary Biliary Cholangitis

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 enrolled 165 participants across four groups during the main double-blind phase (lasting about 12 weeks): 38 people received obeticholic acid (OCA) at 10 mg, 48 received OCA at 25 mg, 41 received OCA at 50 mg, and 38 received a placebo (a dummy treatment with no active ingredient). After the main phase, 78 participants moved into a longer follow-up phase lasting up to 12 months, where everyone received OCA. The trial was measuring changes in certain blood markers — particularly a liver-related enzyme called alkaline phosphatase (ALP) — to see how the levels shifted over time in each group. The reported data shows that the main goal of the trial was to measure the percentage change in ALP levels from the start to the end of the 12-week double-blind phase. According to the results reported on ClinicalTrials.gov, ALP levels fell by around 23.7% in the 10 mg OCA group, 24.7% in the 25 mg group, and 21.0% in the 50 mg group, compared to a drop of about 2.6% in the placebo group. The reported data also shows changes in other liver-related blood markers (AST, ALT, and GGT) and a protein called albumin. Across the OCA groups, those markers also showed reported percentage reductions ranging roughly from 13% to 29% over the 12 weeks, while the placebo group showed much smaller reported changes (generally under 5%). During the longer follow-up phase, the reported data shows continued reductions in ALP of around 22–24% from the start of that phase, with more modest reported changes in the other markers. 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 25500425) ↗

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.

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 are between 18 and 70 years old (male or female).
You have been taking a stable dose of ursodeoxycholic acid (a liver medication) for at least 6 months before the screening visit.
If you are a woman, you are past menopause, have had surgery to prevent pregnancy, or are willing to use 2 forms of contraception during the study and for 14 days after finishing the medication.
If you are a man, you are willing to use 2 forms of contraception during the study and for 14 days after finishing the medication.
You have been diagnosed with, or are likely to have, Primary Biliary Cholangitis (PBC), shown by at least 2 of these 3 things: elevated liver enzyme levels (AP) for at least 6 months, a positive blood test result linked to PBC, or a liver biopsy that matches PBC.
Your AP liver enzyme level at screening falls within a specific range (between 1.5 and 10 times the upper limit of normal) (confirm with trial site).

Who may not be able to join:

You have taken certain medications — colchicine, methotrexate, azathioprine, or steroid tablets/injections — at any point in the 3 months before screening.
Your bilirubin (a liver marker measured in a blood test) is more than 2 times the upper limit of normal at screening.
Your ALT or AST liver enzyme levels are more than 5 times the upper limit of normal at screening.
Your kidney function blood test (creatinine) result is above a certain level at screening (confirm with trial site).
You have a history of serious liver complications such as internal bleeding from swollen veins, confusion caused by liver disease, or severe fluid build-up in the abdomen.
You have another liver condition at the same time, such as hepatitis B or C, primary sclerosing cholangitis, alcohol-related liver disease, autoimmune liver disease, or a type of liver disease related to fat build-up (NASH).
You are currently pregnant.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT00550862

Sponsor: Intercept Pharmaceuticals

Phase: Phase 2

Status: Terminated

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT00550862

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are between 18 and 70 years old (male or female).
You have been taking a stable dose of ursodeoxycholic acid (a liver medication) for at least 6 months before the screening visit.
If you are a woman, you are past menopause, have had surgery to prevent pregnancy, or are willing to use 2 forms of contraception during the study and for 14 days after finishing the medication.
If you are a man, you are willing to use 2 forms of contraception during the study and for 14 days after finishing the medication.
You have been diagnosed with, or are likely to have, Primary Biliary Cholangitis (PBC), shown by at least 2 of these 3 things: elevated liver enzyme levels (AP) for at least 6 months, a positive blood test result linked to PBC, or a liver biopsy that matches PBC.
Your AP liver enzyme level at screening falls within a specific range (between 1.5 and 10 times the upper limit of normal) (confirm with trial site).

Who may not be able to join:

You have taken certain medications — colchicine, methotrexate, azathioprine, or steroid tablets/injections — at any point in the 3 months before screening.
Your bilirubin (a liver marker measured in a blood test) is more than 2 times the upper limit of normal at screening.
Your ALT or AST liver enzyme levels are more than 5 times the upper limit of normal at screening.
Your kidney function blood test (creatinine) result is above a certain level at screening (confirm with trial site).
You have a history of serious liver complications such as internal bleeding from swollen veins, confusion caused by liver disease, or severe fluid build-up in the abdomen.
You have another liver condition at the same time, such as hepatitis B or C, primary sclerosing cholangitis, alcohol-related liver disease, autoimmune liver disease, or a type of liver disease related to fat build-up (NASH).
You are currently pregnant.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Terminated

Phase

Phase 2

Sponsor

Intercept Pharmaceuticals

Registry

ClinicalTrials.gov

Start date

1 October 2007

Est. completion

1 August 2009

Where this trial is recruiting

🇦🇹 Austria 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇳🇱 Netherlands 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov