NCT00930995

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

First QC Date

July 1, 2009

Last Update Submit

April 23, 2012

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry

    48 weeks

  • • Hepatic fibrosis by morphometry

    48 weeks

Secondary Outcomes (2)

  • Surrogate markers for fibrosis (liver TGF-beta levels, serum procollagen-III peptide levels)

    48 weeks

  • Functional status- Albumin, INR, T. Bilirubin, MELD score

    48 weeks

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Candesartan

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CandesartanDRUG

16mg po daily

Also known as: Atacand
A
PlaceboDRUG

once daily

B

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente

Roseville, California, 95661, United States

Location

Kaiser Permanente

Sacramento, California, 95825, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

candesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Sripriya Subramanian, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 2, 2009

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

US(2)