NCT04650243 Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
| NCT ID | NCT04650243 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Primary Biliary Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2020-01-21 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2020-01-21 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 effect of therapy will be evaluated every three months.
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) after 6 to 12 months treatment of UDCA; * Informed consent obtained. Exclusion Criteria: * 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 subjects, etc.; * Participating in other clinical trials or participated in other clinical trials in three months.
Contact & Investigator
Li Wang
STUDY DIRECTOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT04650243 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Biliary Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04650243 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04650243 currently recruiting?
Yes, NCT04650243 is actively recruiting participants. Contact the research team at wangli2221@sina.com for enrollment information.
Where is the NCT04650243 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04650243 clinical trial?
NCT04650243 is sponsored by Peking Union Medical College Hospital. The principal investigator is Li Wang at Peking Union Medical College Hospital. The trial plans to enroll 90 participants.