Status:
WITHDRAWN
Angiotensin Receptor Blockade as an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
University of California, Davis
Conditions:
Hepatitis C
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00930995
Last Update
April 25 2012
Active Locations (2)
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1
Kaiser Permanente
Roseville, California, United States, 95661
2
Kaiser Permanente
Sacramento, California, United States, 95825