Moexipril for Primary Biliary Cirrhosis

NCT00588302 | Completed Phase 2 DMC

• 1 other identifier: 1032-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Primary Biliary Cirrhosis

Keywords

primary biliary cirrhosis; ursodeoxycholic acid

Outcome Measures

Primary Outcomes (1)

• change in liver biochemistries and Mayo risk score for PBC

  12 months

Secondary Outcomes (1)

• change in health-related quality of life in PBC

  12 months

Study Arms (1)

A, 1

EXPERIMENTAL

All patients received an open-label moexipril during the study period.

Drug: Moexipril

Interventions

Moexipril DRUG

Moexipril was given at a starting dose of 7.5 mg daily for 1 week to all enrolled patients. If tolerated (no clinically significant hypotension or medication associated adverse event), the daily dosage was increased to 15 mg daily at the beginning of the 2nd treatment week. Patients took moexipril orally in the morning and 1 hour prior to food intake. The target dose was maintained for the 1-year period of the study unless the development of toxicities warranted dose reduction or discontinuation.

A, 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• UCB Pharma: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Talwalkar JA, Lindor KD. Primary biliary cirrhosis. Lancet. 2003 Jul 5;362(9377):53-61. doi: 10.1016/S0140-6736(03)13808-1.

  PMID: 12853201 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

moexipril

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith D Lindor, MD

  Mayo Clinic and Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: June 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

US (1)