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Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis

Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020160
Enrollment
Unknown
Registered
2018-12-18
Start date
2018-12-20
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

Interventions

1:Fenofibrate+UDCA
2:UDCA

Sponsors

Peking Union Medical College Hosipital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Satisfied the diagnostic criteria of PBC by the AASLDin 2000; (2) Aged 18-65 years old; (3) Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase); (4) Patients with abormal ALP and/or GGT after 6 months treatment of UDCA.

Exclusion criteria

Exclusion criteria: 1. Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN; 2. decompensation of liver function (Child grade B/C); 3. combined with tumor; 4. complicated with important organ failure (such as renal insufficiency), serious infection or other serious complications; 5. pregnancy, preparation for pregnancy or pregnancy Lactation, psychiatric subjects, etc.; 6. People with a history of serious drug allergy or allergic constitution; 7. Patients with markedly elevated blood lipids (such as triglyceride > 500mg/dl) requiring lipid lowering therapy, or who have already treated by statins; 8. Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
ALP;

Countries

China

Contacts

Public ContactLi Wang

Peking Union Medical College Hospital

wangli2221@sina.com+86 13801175089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026