A Phase 3 interventional study of Fenofibrate and UDCA in Primary Biliary Cirrhosis, sponsored by Xijing Hospital of Digestive Diseases. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Xijing Hospital of Digestive Diseases · Phase 3, Interventional, and Treatment
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 104 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fenofibrate in combination with ursodeoxycholic acid
Drug: Fenofibrate · Drug: UDCA
UDCA alone
Drug: UDCA
Rate of patients with complete biochemical response
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
Time frame: Week 24
Change in liver biopsy examinations according to conventional Ludwig system.
Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages.
Time frame: Week 48
Change in GLOBE risk scores after treatment.
The prognostic scores will be calculated at entry and end of study by GLOBE scoring system, which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of treatment and age at baseline.
Time frame: Week 48
Change in liver stiffness status measured by magnetic resonance elastography.
The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.
Time frame: Week 48
Change in serum levels of ALP compared to the baseline.
Absolute change in serum levels of ALP compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of bilirubin compared to the baseline.
Absolute change in serum levels of bilirubin compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of transaminase compared to the baseline.
Absolute change in serum levels of transaminase compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in symptom-pruritus.
The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.
Time frame: Week 24
Change in symptom-fatigue.
The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.
Time frame: Week 24
Change in serum Immunoglobulin M Levels.
Absolute change in serum levels of Immunoglobulin M compared to the baseline.
Time frame: Week 24
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Xijing Hospital of Digestive Diseases