Primary Biliary Cirrhosis Clinical Trial
Official title:
Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
Verified date | February 2021 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.
Status | Active, not recruiting |
Enrollment | 11 |
Est. completion date | July 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD]: - History of elevated alkaline phosphatase levels. - Anti-mitochondrial antibodies positivity - Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts. - Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day). - Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria. - Written informed consent. - Age = 18 years. Exclusion Criteria: - Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy). - Coexistence autoimmune hepatitis. - Bilirrubin >3mg/dl. - For females, pregnancy or breast-feeding. - Hepatocellular carcinoma. - History or presence of spontaneous bacterial peritonitis. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Mexicano de Seguro Social | Puebla |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical response | Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl. | 6 months | |
Secondary | Quality of life | Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire | Baseline and 6 months later | |
Secondary | Pruritus intensity | Evaluation made by the use of visual analogue scales. | Baseline and 6 months later |
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