Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Recruiting
Phase 4
Interventional Study
Primary Biliary Cholangitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Other
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About This Trial
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. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The e…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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) …
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