Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (BEZURSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01654731|
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : August 28, 2018
|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.|
|Actual Study Start Date :||October 15, 2012|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|