Moexipril for Primary Biliary Cirrhosis

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo risk score, and health-related quality of life in patients with primary biliary cirrhosis (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: UCB Pharma
• Treatments: Moexipril

Criteria

Inclusion Criteria:

• PBC patients treated with UDCA (daily dose of 13 to 15 mg/kg for at least 6 months) and an incomplete response defined by persistent elevation of serum alkaline phosphatase activity at least 2 times the upper limit of normal

Exclusion Criteria:

• age less than 18 years

• pregnancy or nursing

• anticipated need for liver transplantation within 1 year with less than a 80% one-year survival determined by the Mayo risk score

• complications of cirrhosis such as recurrent variceal hemorrhage, portosystemic encephalopathy, and refractory ascites

• history of coexistent severe cardiovascular disease including aortic stenosis

• history of coexistent severe renal disease (defined as elevation of serum creatinine more than 1.5 mg/dL) including renal artery stenosis

• history of allergy to ACE inhibitors

• current use of an ACE inhibitors or AT1 receptor antagonists in the past 3 months

• previous treatment with immunosuppressive agents or any experimental drug in the preceding 3 months.