A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
- Conditions
- Chronic Hepatitis CEnd Stage Renal Disease
- Interventions
- Registration Number
- NCT01731301
- Lead Sponsor
- Liver Institute of Virginia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ribavirin, peginterferon, boceprevir Ribavirin The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir. Ribavirin, peginterferon, boceprevir Peginterferon The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir. Ribavirin, peginterferon, boceprevir Boceprevir The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
- Primary Outcome Measures
Name Time Method Percentage of patients who achieve eRVR at treatment week 28 28 weeks The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
- Secondary Outcome Measures
Name Time Method Tolerability of treatment 48 weeks A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR
Trial Locations
- Locations (1)
Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States