Angiotensin Receptor Blockade as an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C

NCT ID: NCT00930995

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

Hepatitis C is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Morbidity and mortality from hepatitis C are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. Efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions.

Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. Thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis C.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Candesartan

Intervention Type: DRUG

16mg po daily

B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

once daily

Interventions

Candesartan

16mg po daily

Intervention Type: DRUG

Placebo

once daily

Intervention Type: DRUG

Other Intervention Names

Atacand

Eligibility Criteria

Inclusion Criteria

• Adults, age 21 and older
• Patients with viral hepatitis C that are not on interferon based therapy.
• Detectable viral load
• Baseline biopsy within six months or willing to undergo biopsy prior to drug initiation
• At least grade 2 inflammation on biopsy, fibrosis of stage 1 or higher
• Willing to undergo biopsy at the end of treatment
• No interferon for at least 6 months prior to or after initial biopsy for study

Exclusion Criteria

• Renal impairment defined by a serum creatinine of >1.8
• Congestive heart failure
• Hepatocellular cancer
• Concurrent treatment with pentoxyfylline, steroids, interferon alpha or interferon gamma.
• Active psychosis (affective disorders without loss of reality testing acceptable)
• Active IV drug use
• Prior liver transplant
• Pregnancy
• Decompensated cirrhosis as defined by the presence of ascites, hepatic encephalopathy or coagulopathy with an INR>1.4
• HIV seropositivity
• Hypotension defined by a baseline systolic blood pressure of less than 90mm of mercury
• Contraindication to ARB use or allergy to medication
• Treatment with potassium sparing diuretics

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Kaiser Permanente

Principal Investigators

Sripriya Subramanian, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente

Roseville, California, United States

Kaiser Permanente

Sacramento, California, United States

Countries

United States

Other Identifiers

CN-05SBala-01-B

Identifier Type: -

Identifier Source: org_study_id