A Phase 1/2 interventional study of Fenofibrate and UDCA in Primary Biliary Cirrhosis, sponsored by Beijing 302 Hospital. Withdrawn at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Beijing 302 Hospital · Phase 1/2, Interventional, and Treatment
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.
Browse Liver Cirrhosis, Biliary studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
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3,signed informed consent after careful review of information and study details.
Exclusion Criteria:
All subjects will reiceive UDCA at a dose of 13-15mg/kg/d by oral for 12 months, and UDCA will be maintained after 12 months.
Drug: UDCA
All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,
Drug: Fenofibrate · Drug: UDCA
Fenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels.
Also known as: Antara, Fenoglide, Fibricor, Lipofen, Lofibra
Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC.
Also known as: Ursa，Urso, Urso Forte, Ursocol, Ursofalk,
Serum Level of Alkaline Phosphatase(ALP) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time frame: 12 months
Total bilirubin(TBIL) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time frame: 12 months
Aspartate aminotransferase(AST) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time frame: 12 months
Serum Level of Gamma-glutamyl transpeptidase (GGT) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time frame: 12 months
Plan to share: No
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This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Beijing 302 Hospital