Phase 2 Primary Biliary Cholangitis Trial, Terminated (NCT03394781)

Phase 2 Primary Biliary Cholangitis Trial, Terminated NCT03394781 Sponsor: Durect Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT03394781 — 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 a total of five people — three in a group receiving a 10 mg dose of a study drug called DUR-928, and two in a group receiving a 50 mg dose. All five participants completed the trial; none dropped out. The trial was measuring changes in certain liver-related substances in the blood — mainly a liver enzyme called alkaline phosphatase (ALP), along with other liver enzymes and bile acids (natural substances made by the liver) — to see how those levels shifted from the start of the trial to the end of treatment and a follow-up period. The reported data shows that, for the primary measurement (change in ALP levels), the 10 mg group had reported changes of around 23.7% and 10.7% at different time points, while the 50 mg group had reported changes of around 16.8% and 11.05%. For the secondary measurements covering other liver enzymes and bile acids, the reported figures varied quite a bit between the two groups and across different time points — for example, one bile acid measure showed a reported change of approximately −13.9% in the 10 mg group and −44.1% in the 50 mg group (a negative number here means a reduction from baseline). The reported data shows that no participants in either group were recorded as having a reduction in ALP that met the threshold being tracked in one of the secondary measures. For the final secondary outcome — changes in selected biomarkers (biological markers measured in the blood) — no data was reported. It is worth noting that with only five participants in total, this was a very small trial, and the numbers above simply describe what was recorded and submitted. 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 have been officially diagnosed with primary sclerosing cholangitis (PSC) for at least 12 months, with or without a bowel condition called inflammatory bowel disease (IBD).
A specific liver enzyme in your blood (called alkaline phosphatase) is at least 1.5 times higher than the normal upper limit, and this level has stayed roughly the same (within 15%) over the past 3 months.
If you are currently taking a medication called ursodeoxycholic acid (UDCA), your dose must have been stable for at least 3 months and must not exceed 20 mg/kg/day.
If you are able to become pregnant, you must agree to use a reliable form of contraception throughout the trial and for up to 2 months after your last dose of the study drug.

Who may not be able to join:

You have been diagnosed with a different type of sclerosing cholangitis (called secondary sclerosing cholangitis or small duct PSC).
You had a bile duct infection (bacterial cholangitis) within the 30 days before your screening appointment.
You currently have a drain through the skin or a stent (small tube) placed in your bile duct.
You have a history of, or suspected, bile duct cancer (cholangiocarcinoma).
You have previously had a liver transplant, or you are currently on the waiting list for one.
You have another liver disease in addition to PSC.
You have moderate to severe active IBD, or your bowel condition has flared up within the last 3 months.
You have a serious and/or untreated heart, kidney, hormonal, or mental health condition.
You have had any cancer (other than certain common skin cancers) within the past 3 years.
You have HIV.
You are currently pregnant, planning to become pregnant, or breastfeeding.
You have taken part in another clinical trial and received a study medication within the past 30 days.

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: NCT03394781

Sponsor: Durect

Phase: Phase 2

Status: Terminated

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT03394781

Eligibility summary (AI generated)

Written by an AI model from the 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 officially diagnosed with primary sclerosing cholangitis (PSC) for at least 12 months, with or without a bowel condition called inflammatory bowel disease (IBD).
A specific liver enzyme in your blood (called alkaline phosphatase) is at least 1.5 times higher than the normal upper limit, and this level has stayed roughly the same (within 15%) over the past 3 months.
If you are currently taking a medication called ursodeoxycholic acid (UDCA), your dose must have been stable for at least 3 months and must not exceed 20 mg/kg/day.
If you are able to become pregnant, you must agree to use a reliable form of contraception throughout the trial and for up to 2 months after your last dose of the study drug.

Who may not be able to join:

You have been diagnosed with a different type of sclerosing cholangitis (called secondary sclerosing cholangitis or small duct PSC).
You had a bile duct infection (bacterial cholangitis) within the 30 days before your screening appointment.
You currently have a drain through the skin or a stent (small tube) placed in your bile duct.
You have a history of, or suspected, bile duct cancer (cholangiocarcinoma).
You have previously had a liver transplant, or you are currently on the waiting list for one.
You have another liver disease in addition to PSC.
You have moderate to severe active IBD, or your bowel condition has flared up within the last 3 months.
You have a serious and/or untreated heart, kidney, hormonal, or mental health condition.
You have had any cancer (other than certain common skin cancers) within the past 3 years.
You have HIV.
You are currently pregnant, planning to become pregnant, or breastfeeding.
You have taken part in another clinical trial and received a study medication within the past 30 days.

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

Durect

Registry

ClinicalTrials.gov

Start date

22 January 2018

Est. completion

31 January 2019

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent Change of Alkaline Phosphatase (ALP) From Baseline

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