Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT00930995
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00930995
Study Brief:
Protocol Section:
NCT00930995