Phase 2 Primary Biliary Cholangitis Trial, Terminated (NCT03359174)

Phase 2 Primary Biliary Cholangitis Trial, Terminated NCT03359174 Sponsor: Yale University Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT03359174 — 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 looked at a treatment called All-trans Retinoic Acid (ATRA) in people with a liver condition. The trial set out to measure changes in certain blood markers — including a liver enzyme called alkaline phosphatase (ALP), bile acids, and other indicators of liver health — by comparing blood test results before and after treatment. Only 2 people enrolled in the trial, 1 of whom completed it and 1 of whom did not finish. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (change in ALP levels) nor any of the six secondary measures (such as changes in bile acids, liver enzymes, or a liver scarring score). Because no measurement data was reported, it is not possible to describe what the blood tests showed for either participant. Given the very small number of participants and the absence of any reported numerical results, the data as submitted does not allow any conclusions to be drawn about the outcomes being studied. 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 ↗

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 80 years old (male or female)
You have been diagnosed with a specific liver/bile duct condition called large-duct PSC (Primary Sclerosing Cholangitis), confirmed by imaging or biopsy, for at least 6 months
Your blood test results have shown a liver enzyme called ALP to be consistently above 1.5 times the normal upper limit for the past 6 months
You have stopped taking a medication called ursodeoxycholic acid (also known as ursodiol) at least 3 months ago
If you are male or a female who could become pregnant, you are willing to use at least 2 forms of barrier contraception during the trial

Who may not be able to join:

You have a different or related form of PSC (small-duct), or your PSC overlaps with another liver condition such as autoimmune hepatitis, IgG4 disease, or secondary sclerosing cholangitis
You have been diagnosed with cancer in the past 5 years (with some exceptions for certain minor skin cancers or very early-stage cancers — confirm with trial site)
You have or have had a viral hepatitis infection (types A, B, C, D, or E)
Your liver disease is at an advanced stage (decompensated cirrhosis), or you are already planning to have a liver transplant
You have had a bile duct procedure (such as a scope or imaging-guided treatment) within the past 3 months
You have had a serious bile duct infection requiring antibiotics within the past 3 months
You have inflammatory bowel disease (IBD) that is not well controlled, or you are currently taking steroid medications for IBD
You have kidney problems with a specific blood test result (creatinine) above a certain level (confirm with trial site)
You have a known allergy to ATRA or vitamin A-related compounds

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: NCT03359174

Sponsor: Yale University

Phase: Phase 2

Status: Terminated

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT03359174

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 80 years old (male or female)
You have been diagnosed with a specific liver/bile duct condition called large-duct PSC (Primary Sclerosing Cholangitis), confirmed by imaging or biopsy, for at least 6 months
Your blood test results have shown a liver enzyme called ALP to be consistently above 1.5 times the normal upper limit for the past 6 months
You have stopped taking a medication called ursodeoxycholic acid (also known as ursodiol) at least 3 months ago
If you are male or a female who could become pregnant, you are willing to use at least 2 forms of barrier contraception during the trial

Who may not be able to join:

You have a different or related form of PSC (small-duct), or your PSC overlaps with another liver condition such as autoimmune hepatitis, IgG4 disease, or secondary sclerosing cholangitis
You have been diagnosed with cancer in the past 5 years (with some exceptions for certain minor skin cancers or very early-stage cancers — confirm with trial site)
You have or have had a viral hepatitis infection (types A, B, C, D, or E)
Your liver disease is at an advanced stage (decompensated cirrhosis), or you are already planning to have a liver transplant
You have had a bile duct procedure (such as a scope or imaging-guided treatment) within the past 3 months
You have had a serious bile duct infection requiring antibiotics within the past 3 months
You have inflammatory bowel disease (IBD) that is not well controlled, or you are currently taking steroid medications for IBD
You have kidney problems with a specific blood test result (creatinine) above a certain level (confirm with trial site)
You have a known allergy to ATRA or vitamin A-related compounds

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

Yale University

Registry

ClinicalTrials.gov

Start date

29 May 2018

Est. completion

1 December 2020

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change of 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