Recruiting PHASE4 Primary Biliary Cholangitis

New treatment option for Primary Biliary Cholangitis

Official title Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

ClinicalTrials.gov ID: NCT04650243

What this study is testing

What is ursodeoxycholic acid?

ursodeoxycholic acid is an investigational medicine, being studied as a potential treatment for primary biliary cholangitis.

Also referred to as UDCA.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Satisfied the diagnostic criteria of PBC by the AASLDin 2000;
  • Age≥18 years
  • Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase);
  • Patients with improved liver biochemical index( ALP and AST≤1.5× upper limit of normal, with a normal bilirubin level) after 6 to 12 months treatment...
  • Informed consent obtained.

You likely can't join if

  • Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN;
  • Decompensation of liver function (Child grade B/C);
  • Complicated with important organ failure (such as renal insufficiency), serious infection or other serious complications;
  • Pregnancy, preparation for pregnancy or pregnancy Lactation, psychiatric people, etc.;
  • Participating in other clinical trials or participated in other clinical trials in three months.

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, China

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.