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

Status unconfirmed · Phase 4

Conditions studied: Chronic Hepatitis C, End Stage Renal Disease

In brief

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)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. 3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

Key facts

Study ID

NCT01731301

Run by

Liver Institute of Virginia

People needed

20

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2012-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Liver Institute of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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