Expired Study
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Rochester, Minnesota 55905


Purpose:

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).


Study summary:

Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease of presumed autoimmune cause characterized by progressive inflammatory destruction of interlobular and septal bile ducts, resulting in fibrosis and eventual cirrhosis (1). In PBC patients, the most disabling symptoms are fatigue and pruritus which diminish health-related quality of life (HRQL. Ursodeoxycholic acid (UDCA), at a dose of 13 to 15 mg/kg per day, is a safe and effective medical therapy for most patients with PBC. Nevertheless, UDCA therapy has not ameliorated symptoms associated with PBC. Some UDCA-treated patients show progressive disease resulting in the liver transplantation or death from liver-related causes. For these patients, who show a persistent elevation of serum alkaline phosphatase at least twice the normal level after 6 months of UDCA monotherapy (incomplete responders), the evaluation of combination therapy in clinical trials has been recommended. Moexipril is a long-acting, nonsulfhydryl ACE inhibitor with lipophilicity, and so can readily penetrate lipid membranes and thus target tissue ACE in addition to plasma ACE. This drug also demonstrated antioxidative properties in addition to efficiently controlling blood pressure in hypertensive postmenopausal subjects. Moreover, quality-of-life data suggest favorable effects of moexipril treatment in a patient population at high cardiovascular risk. The tolerability and safety profile of moexipril resembles that of other ACE inhibitors along with no reports of hepatotoxicity in controlled trials. Hence, moexipril is an attractive drug for evaluation in patients with chronic liver disease.


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.


Study is Available At:


Original ID:

1032-03


NCT ID:

NCT00588302


Secondary ID:


Study Acronym:


Brief Title:

Moexipril for Primary Biliary Cirrhosis


Official Title:

Open-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Keith D Lindor, MD
Principal Investigator
Mayo Clinic and Foundation

Study Dates

Start Date:June 2003
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 20, 2011
First Received Date:December 22, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:change in health-related quality of life in PBC
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:change in liver biochemistries and Mayo risk score for PBC
Time Frame:12 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Moexipril
Description: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
Arm Name:A, 1

Study Arms

Study Arm Type:Experimental
Arm Name:A, 1
Description:All patients received an open-label moexipril during the study period.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Industry
Agency Type:Collaborator
Agency Name:UCB, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Talwalkar JA, Lindor KD. Primary biliary cirrhosis. Lancet. 2003 Jul 5;362(9377):53-61. Review.
PMID:12853201

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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