Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (BEZURSO)
|ClinicalTrials.gov Identifier: NCT01654731|
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|PBC||Drug: Bezafibrate Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Placebo Comparator: Placebo
1 tablet/ day
- Percentage of patients with complete biochemical response. [ Time Frame: 24 months ]The normalisation of hepatic biochemical tests (aminotransferases (AST, ALT), Alkaline Phosphatase, blood Albumin, blood bilirubin and prothrombin index).
- Percentage of patients having biological or clinical adverse reaction. [ Time Frame: 24 months ]Increase of ALT, AST or CPK > 5N
- Percentage of patients having complete biochemical response. [ Time Frame: 12 months ]Percentage of patients having complete biochemical response at Month 12.
- Evolution of the pruritus. [ Time Frame: 24 months ]Pruritus is measured via visual analogical scale every 3 months from month 0 to month 24
- Assessment of the fatigue and the quality of life. [ Time Frame: 24 months ]Measured via French questionnaire version of NHP (Nottingham Health Profile) every 12 months from month 0 to month 24
- Evolution of liver fibrosis surrogate markers. [ Time Frame: 24 months ]assessment of hyaluronic acid serum concentration and hepatic transient elastography (Fibroscan®)
- Evolution of the portal hypertension markers. [ Time Frame: 24 months ]Occurrence of ascites, decrease in the platelet count below 150000/mm3 or of more than 30% of its initial value, evolution of the ultrasound data of the splanchnic circulation, occurrence or size progression of oesophageal varices (endoscopy)
- Histological evolution: Histopathological examination of biological sample before enrolment and at the end of the study. [ Time Frame: 24 months ]Quantification of the fibrosis and the inflammatory and destructive injuries.
- Evolution of the biological markers of the hepatic function or being in the usual prognostic scores (Mayo, Child, MELD). [ Time Frame: 24 months ]Blood albumin, prothrombin time, INR, blood bilirubin, creatinine blood level.
- Survival without transplantation and hepatic impairment. [ Time Frame: 24 months ]Occurrence of ascites, a digestive variceal bleeding, a hepatic encephalopathy, or a doubling of the total blood bilirubin exceeding the threshold of 50 µmols/L (3 mg/dl).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654731
|Hepatology department - Hopital Saint Antoine|
|Paris, France, 75012|
|Principal Investigator:||Christophe Corpechot, Doctor||Assistance Publique|