NCT05751967 Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
| NCT ID | NCT05751967 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Primary Biliary Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2027-12-01 |
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 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2023-02-22 with a primary completion date of 2027-12-01.
⚠ 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
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.
Eligibility Criteria
Inclusion Criteria: * Must have provided written informed consent; * Age 18-75 years; * BMI 17-28 kg/m2 * Male or female with a diagnosis of PBC, by at least two of the following criteria: * History of AP above ULN for at least six months; * Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies; * Documented liver biopsy result consistent with PBC. * Incomplete response to UDCA defined by Xi'an criteria (ALP \>2.5× ULN, AST\>2×ULN or TBIL\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL. Exclusion Criteria: * History or presence of other concomitant liver diseases. * ALT/AST \> 5×ULN, TBIL \> 3×ULN. * If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * Allergic to fenofibrate or ursodeoxycholic acid. * Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. * Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min. * Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * Planned to receive an organ transplant or an organ transplant recipient. * Needing Liver transplantation within 1 year according to the Mayo Rick score. * Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.
Contact & Investigator
Ying Han, Doctor
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Air Force Medicial University
Frequently Asked Questions
Who can join the NCT05751967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, 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 NCT05751967 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT05751967 currently recruiting?
Yes, NCT05751967 is actively recruiting participants. Contact the research team at shangyl870222@163.com for enrollment information.
Where is the NCT05751967 trial being conducted?
This trial is being conducted at Lanzhou, China, Guangzhou, China, Nanjing, China, Shenyang, China and 3 additional locations.
Who is sponsoring the NCT05751967 clinical trial?
NCT05751967 is sponsored by Xijing Hospital of Digestive Diseases. The principal investigator is Ying Han, Doctor at The First Affiliated Hospital of Air Force Medicial University. The trial plans to enroll 150 participants.