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UNKNOWNPhase 4NCT01731301

A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoin...

Lead sponsor: Liver Institute of Virginia•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Mitchell L Shiffman, MD

CONTACT

804-977-8920 mitchell_shiffman@bshsi.org

April G. Long, NP

CONTACT

804-977-8920 april_long@bshsi.org

Sponsors

Lead Sponsor

Liver Institute of Virginia

Collaborators

Merck Sharp & Dohme LLC
Chronic Liver Disease Foundation

Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Chronic HCV defined by:
•A history of a positive anti-HCV or HCV RNA for \> 6 months or
•A liver biopsy demonstrating at least portal fibrosis
•HCV genotype 1
•No prior treatment with any interferon or peginterferon preparation
•ESRD undergoing hemodialysis for at least 6 months
•Willingness not to conceive a child during treatment and for 6 months following discontinuation of treatment.

Exclusion Criteria

•Histologic evidence of cirrhosis
•Any co-existent liver disease
•A platelet count \< 90,000
•A total white blood cell (WBC) \< 2.5
•An absolute neutrophil count \< 1.5
•Hemoglobin \< 11 gm/dl on Epoetin-alpha
•Positive test for anti-HIV
•Pregnancy of the patient or their intimate partner
•Women who are breast feeding
•Significant cardiovascular disease
•History of suicide intent, severe depression requiring hospitalization or significant psychiatric disease
•Malignancy within 5 years of enrollment except for squamous or basal cell skin cancer
•Co-existent immune disorder such as lupus, rheumatoid as arthritis, colitis, Crohns disease, sarcoidosis, etc.
•Any patient in the opinion of the investigator who would not be a satisfactory study candidate

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 22, 2012Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE4

Enrollment20

Start dateJan 2013

Last updatedNov 22, 2012

Condition

Chronic Hepatitis C End Stage Renal Disease

Locations shown

Liver Institute of Virginia

Richmond, Virginia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2012Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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