Chronic Hepatitis C | A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Chronic Hepatitis C research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Hepatitis C
End Stage Renal Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RibavirinRibavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.
Drug:PeginterferonAfter the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.
Drug:BoceprevirBoceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Ribavirin, peginterferon, boceprevirThe efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
Start Date: January 2013
Completed Date: January 2015
Phase: Phase 4
Primary Outcome: Percentage of patients who achieve eRVR at treatment week 28
Secondary Outcome: Tolerability of treatment
Study sponsors, principal investigator, and references
Principal Investigator: Mitchell L Shiffman, MD
Lead Sponsor: Liver Institute of Virginia