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

Sponsor
Kaiser Permanente (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00930995
Collaborator
University of California, Davis (Other)
0
Enrollment
2
Locations
2
Arms
0
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Angiotensin Receptor Blockade an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Drug: Candesartan
16mg po daily
Other Names:
  • Atacand

    		•
    Placebo Comparator: B

    Drug: Placebo
    once daily

    Outcome Measures

    Primary Outcome Measures

    1. Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry [48 weeks]

    2. • Hepatic fibrosis by morphometry [48 weeks]

    Secondary Outcome Measures

    1. Surrogate markers for fibrosis (liver TGF-beta levels, serum procollagen-III peptide levels) [48 weeks]

    2. Functional status- Albumin, INR, T. Bilirubin, MELD score [48 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Roseville California United States 95661
    2 Kaiser Permanente Sacramento California United States 95825

    Sponsors and Collaborators

    • Kaiser Permanente
    • University of California, Davis

    Investigators

    • Principal Investigator: Sripriya Subramanian, MD, MPH, Kaiser Permanente

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00930995
    Other Study ID Numbers:
    • CN-05SBala-01-B
    First Posted:
    Jul 2, 2009
    Last Update Posted:
    Apr 25, 2012
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Candesartan

    Study Results

    No Results Posted as of Apr 25, 2012