This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been withdrawn prior to enrollment.
(Not Awarded)
University of California, Davis
Information provided by:
Kaiser Permanente Identifier:
First received: July 1, 2009
Last updated: April 23, 2012
Last verified: April 2012

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 Intervention Phase
Hepatitis C Drug: Candesartan Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry [ Time Frame: 48 weeks ]
  • • Hepatic fibrosis by morphometry [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Surrogate markers for fibrosis (liver TGF-beta levels, serum procollagen-III peptide levels) [ Time Frame: 48 weeks ]
  • Functional status- Albumin, INR, T. Bilirubin, MELD score [ Time Frame: 48 weeks ]

Enrollment: 0
Arms Assigned Interventions
Active Comparator: A Drug: Candesartan
16mg po daily
Other Name: Atacand
Placebo Comparator: B Drug: Placebo
once daily


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00930995

United States, California
Kaiser Permanente
Roseville, California, United States, 95661
Kaiser Permanente
Sacramento, California, United States, 95825
Sponsors and Collaborators
Kaiser Permanente
University of California, Davis
Principal Investigator: Sripriya Subramanian, MD, MPH Kaiser Permanente
  More Information

Responsible Party: Sripriya Balasubramanian MD MPH, Kaiser Permanente Identifier: NCT00930995     History of Changes
Other Study ID Numbers: CN-05SBala-01-B
Study First Received: July 1, 2009
Last Updated: April 23, 2012

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017