Phase 3 Primary Biliary Cholangitis Trial, Terminated (NCT00059202)

Phase 3 Primary Biliary Cholangitis Trial, Terminated NCT00059202 Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT00059202 — 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 150 people — 76 in the ursodeoxycholic acid (a bile acid medication) group and 74 in the placebo (inactive treatment) group. The trial was studying a liver condition called primary sclerosing cholangitis over up to five years. The main thing researchers were tracking was "treatment failure," which they defined as a combination of serious events: death, needing a liver transplant, reaching a threshold of liver disease severity that qualifies someone for transplant listing, developing enlarged blood vessels in the oesophagus or stomach (varices), developing a type of bile duct cancer (cholangiocarcinoma), or the liver disease progressing to cirrhosis (severe scarring). The reported data shows that, for the main outcome, 30 out of 76 people (about 39%) in the ursodeoxycholic acid group experienced one of these treatment failure events, compared with 19 out of 74 people (about 26%) in the placebo group. For the individual secondary outcomes tracked over up to five years: 5 deaths were reported in the medication group versus 3 in the placebo group; 11 people in the medication group received a liver transplant compared with 5 in the placebo group; 13 versus 10 participants reached the transplant-listing disease severity threshold; 2 versus 2 developed bile duct cancer; and 15 versus 5 developed varices. The reported data does not include a breakdown of how many participants progressed to cirrhosis separately from the other events. It is worth noting that more people in the placebo group did not complete the study (15 people) compared with the medication group (6 people), which the reported data does not explain further. 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 19585548) ↗

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 have had a long-term liver/bile duct condition (causing a build-up of bile) lasting at least 6 months.
Your blood test shows that a liver enzyme called alkaline phosphatase is at least one and a half times higher than the normal range.
Within the past year, you have had a special imaging procedure (such as an endoscopy, surgery, needle procedure, or MRI scan) that looked at your bile ducts and showed blockages, narrowing, or irregular beading consistent with a condition called PSC (Primary Sclerosing Cholangitis).
Within the past year, you have had a liver biopsy (a small tissue sample taken from your liver) whose results are available to be reviewed and show signs consistent with PSC, such as scarring around the bile ducts, loss of small bile ducts with inflammation, or liver scarring of a specific type.

Who may not be able to join:

No specific exclusion criteria were listed in the provided information (confirm with trial site).

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 3: approximately ~65% 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: NCT00059202

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phase: Phase 3

Status: Terminated

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT00059202

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 have had a long-term liver/bile duct condition (causing a build-up of bile) lasting at least 6 months.
Your blood test shows that a liver enzyme called alkaline phosphatase is at least one and a half times higher than the normal range.
Within the past year, you have had a special imaging procedure (such as an endoscopy, surgery, needle procedure, or MRI scan) that looked at your bile ducts and showed blockages, narrowing, or irregular beading consistent with a condition called PSC (Primary Sclerosing Cholangitis).
Within the past year, you have had a liver biopsy (a small tissue sample taken from your liver) whose results are available to be reviewed and show signs consistent with PSC, such as scarring around the bile ducts, loss of small bile ducts with inflammation, or liver scarring of a specific type.

Who may not be able to join:

No specific exclusion criteria were listed in the provided information (confirm with trial site).

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 3

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry

ClinicalTrials.gov

Start date

1 July 2002

Est. completion

1 June 2008

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants With Treatment Failure

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