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

Liver Institute of Virginia

Status and phase: Unknown; Phase 4

Conditions: End Stage Renal Disease; Chronic Hepatitis C

Treatments: Drug: Peginterferon; Drug: Boceprevir; Drug: Ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01731301

LIV01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ribavirin, peginterferon, boceprevir

Experimental group

Description:

The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.

Treatment:

Drug: Ribavirin

Drug: Boceprevir

Drug: Peginterferon