Phase 3 Primary Biliary Cholangitis Trial, Completed (NCT01802073)

Phase 3 Primary Biliary Cholangitis Trial, Completed NCT01802073 Sponsor: Stanford University Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT01802073 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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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 (NCT01802073) looked at oral vancomycin — an antibiotic taken by mouth — in people with a liver condition called primary sclerosing cholangitis (PSC). A total of 34 people were enrolled: 14 children and 20 adults. Of those, 9 children and 9 adults completed the trial, while 5 children and 11 adults did not finish. The trial was measuring whether certain liver-related markers in the blood, and images or tissue samples of the liver, showed what the investigators judged to be a clinically significant improvement (meaning a meaningful change based on each person's history and disease stage) after 3 months and 1 year of treatment. The reported data shows the following for the blood marker results at 3 months. For a liver enzyme called ALT (a substance that can rise when the liver is under stress), 10 of the children and 6 of the adults who had elevated levels at the start were recorded as showing a clinically significant improvement. For another liver enzyme called GGT, 8 children and 6 adults with elevated levels at the start were recorded as showing a clinically significant improvement. When ALT and/or GGT were considered together, 10 children and 8 adults were recorded as showing a clinically significant improvement. The reported data also shows results at 1 year for imaging and tissue tests. For a special scan of the bile ducts called an MRCP, 6 children and 4 adults who had abnormal scans at the start were recorded as showing a clinically significant improvement. For liver biopsies (small tissue samples from the liver), 3 children and 0 adults with abnormal results at the start were recorded as showing a clinically significant improvement. When MRCP and/or biopsy results were considered together, 10 children and 4 adults were recorded as showing a clinically significant improvement. 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 23054338) ↗

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 been diagnosed with a liver condition called Primary Sclerosing Cholangitis (PSC), confirmed by a liver biopsy and/or imaging scans.
You have had a colonoscopy within the past year, or are willing to have one at the start of the study.
You either have a bowel condition called Inflammatory Bowel Disease (IBD) alongside your PSC, OR you have PSC without IBD but have had a blood test showing certain markers (p-ANCA or ASCA) that may suggest a link to IBD.

Who may not be able to join:

You have a known allergy to the antibiotic Vancomycin.
You have PSC that is not connected to IBD and your blood tests do not show the specific IBD-related markers (p-ANCA or ASCA).
You have been diagnosed with a type of bile duct cancer called Cholangiocarcinoma.
You are currently taking certain medications, including steroid tablets or steroid-based enemas/suppositories, mesalamine suppositories or enemas, or certain immune-system medications such as infliximab, adalimumab, or certolizumab.

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: NCT01802073

Sponsor: Stanford University

Phase: Phase 3

Status: Completed

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT01802073

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 been diagnosed with a liver condition called Primary Sclerosing Cholangitis (PSC), confirmed by a liver biopsy and/or imaging scans.
You have had a colonoscopy within the past year, or are willing to have one at the start of the study.
You either have a bowel condition called Inflammatory Bowel Disease (IBD) alongside your PSC, OR you have PSC without IBD but have had a blood test showing certain markers (p-ANCA or ASCA) that may suggest a link to IBD.

Who may not be able to join:

You have a known allergy to the antibiotic Vancomycin.
You have PSC that is not connected to IBD and your blood tests do not show the specific IBD-related markers (p-ANCA or ASCA).
You have been diagnosed with a type of bile duct cancer called Cholangiocarcinoma.
You are currently taking certain medications, including steroid tablets or steroid-based enemas/suppositories, mesalamine suppositories or enemas, or certain immune-system medications such as infliximab, adalimumab, or certolizumab.

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

Completed

Phase

Phase 3

Sponsor

Stanford University

Registry

ClinicalTrials.gov

Start date

1 January 2012

Est. completion

1 August 2015

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3; Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3; Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3; Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1; Count of Participants With Abnormal Liver Biopsi...

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

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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