Moexipril for Primary Biliary Cirrhosis
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ClinicalTrials.gov Identifier: NCT00588302 |
Recruitment Status
:
Completed
First Posted
: January 8, 2008
Last Update Posted
: May 23, 2011
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Condition or disease | Intervention/treatment | Phase |
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Primary Biliary Cirrhosis | Drug: Moexipril | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC) |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |

Arm | Intervention/treatment |
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Experimental: A, 1
All patients received an open-label moexipril during the study period.
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Drug: Moexipril
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.
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- change in liver biochemistries and Mayo risk score for PBC [ Time Frame: 12 months ]
- change in health-related quality of life in PBC [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00588302
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Keith D Lindor, MD | Mayo Clinic and Foundation |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00588302 History of Changes |
Other Study ID Numbers: |
1032-03 |
First Posted: | January 8, 2008 Key Record Dates |
Last Update Posted: | May 23, 2011 |
Last Verified: | May 2011 |
Keywords provided by Mayo Clinic:
primary biliary cirrhosis ursodeoxycholic acid |
Additional relevant MeSH terms:
Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis |
Bile Duct Diseases Biliary Tract Diseases Moexipril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |