Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 alkaline phosphatase(ALP) above upper limit of normal(ULN) for at least six months;

⁃ Positive Anti-mitochondrial antibody (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 1 x ULN\< ALP \<= 1.67 x ULN

• Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Sun Yat-sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The second hospital of Lanzhou University
RECRUITING
Lanzhou
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Nanjing Second Hospital
RECRUITING
Nanjing
Shengjing Hospital Affiliated to China Medical University
RECRUITING
Shenyang
Xijing Hospital
RECRUITING
Xi'an
Yan'an University Affiliated Hospital
RECRUITING
Yan’an
Time Frame
Start Date: 2023-08-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 184
Treatments
Experimental: Fenofibrate-ursodesoxycholic acid(UDCA)
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
Placebo_comparator: Placebo-UDCA
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
Sponsors
Leads: Han Ying

This content was sourced from clinicaltrials.gov

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