Primary Biliary Cholangitis Trial, Completed (NCT03545672)

Primary Biliary Cholangitis Trial, Completed NCT03545672 Sponsor: RenJi Hospital Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT03545672 — 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 enrolled 60 people with a liver condition called primary biliary cholangitis (PBC) and 59 people without the condition who acted as a comparison (control) group. The trial was looking at whether people with PBC showed any differences in heart-related measurements compared to healthy controls. A small number of participants did not finish the study — four in the PBC group and three in the control group — leaving 56 completers in each group. The reported data shows two main things were measured. First, the trial tracked whether participants experienced serious heart events — specifically, cardiac death, heart attack, or hospitalisation for unstable chest pain. According to the results reported on ClinicalTrials.gov, the number recorded for each of these events was zero in both groups, meaning none of these events were reported during the follow-up period. Second, the trial used a special heart scan technique called T1 mapping to estimate the amount of a substance called "extracellular volume" (ECV) in the heart muscle — essentially, a way of measuring changes in the heart's tissue structure. The reported data shows the PBC group had an average ECV of 30%, compared to 26% in the control group. 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 34461299) ↗

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:

For people with Primary Biliary Cholangitis (PBC):

You are between 18 and 80 years old
You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: a history of abnormal liver enzyme levels in blood tests, a liver biopsy showing signs of PBC, or a positive result for certain antibodies in your blood
You are able and willing to sign a consent form agreeing to take part

For people joining as a healthy comparison (Control group):

You have no known serious health conditions
Your heart scan (CMR), heart ultrasound (Echo), and heart electrical test (ECG) results are all normal
You are between 18 and 80 years old
You are able and willing to sign a consent form agreeing to take part

Who may not be able to join:

For people with PBC:

You have another liver condition at the same time, such as cirrhosis, viral hepatitis, an inherited liver disease, liver damage caused by medication, or another illness affecting the liver
Doctors estimate you have less than 6 months to live
You have a known heart muscle condition or abnormal results from heart-related tests
Your kidneys do not filter blood well enough, or your heart failure is very severe, making a special heart MRI scan unsafe for you (confirm with trial site)

For people in the healthy comparison group:

You have a known heart condition, such as blocked heart arteries, a heart muscle disease, or another illness affecting the heart
You have a known liver condition, such as viral hepatitis, an inherited liver disease, liver damage caused by medication, or another illness affecting the liver
You have a medical implant or device that makes a special heart MRI scan unsafe for you (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

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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: NCT03545672

Sponsor: RenJi Hospital

Phase: Not Applicable

Status: Completed

Condition: Primary Biliary Cholangitis

More information: https://clinicaltrials.gov/study/NCT03545672

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:

For people with Primary Biliary Cholangitis (PBC):

You are between 18 and 80 years old
You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: a history of abnormal liver enzyme levels in blood tests, a liver biopsy showing signs of PBC, or a positive result for certain antibodies in your blood
You are able and willing to sign a consent form agreeing to take part

For people joining as a healthy comparison (Control group):

You have no known serious health conditions
Your heart scan (CMR), heart ultrasound (Echo), and heart electrical test (ECG) results are all normal
You are between 18 and 80 years old
You are able and willing to sign a consent form agreeing to take part

Who may not be able to join:

For people with PBC:

You have another liver condition at the same time, such as cirrhosis, viral hepatitis, an inherited liver disease, liver damage caused by medication, or another illness affecting the liver
Doctors estimate you have less than 6 months to live
You have a known heart muscle condition or abnormal results from heart-related tests
Your kidneys do not filter blood well enough, or your heart failure is very severe, making a special heart MRI scan unsafe for you (confirm with trial site)

For people in the healthy comparison group:

You have a known heart condition, such as blocked heart arteries, a heart muscle disease, or another illness affecting the heart
You have a known liver condition, such as viral hepatitis, an inherited liver disease, liver damage caused by medication, or another illness affecting the liver
You have a medical implant or device that makes a special heart MRI scan unsafe for you (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

Completed

Phase

Not Applicable

Sponsor

RenJi Hospital

Registry

ClinicalTrials.gov

Start date

23 October 2017

Est. completion

15 August 2019

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The Incidence of Cardiac Events; Quantitative Assessment in Cardiac Injury

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