Boceprevir in End Stage Renal Disease (ESRD)
Hepatitis C Infection, End Stage Renal Disease
About this trial
This is an interventional treatment trial for Hepatitis C Infection focused on measuring Hepatitis C Infection, HCV, genotype 1, End Stage Renal Disease, ESRD, Boceprevir, Pegylated Interferon, Ribavirin
Eligibility Criteria
Inclusion Criteria:
- Adult (ages 18-75)
- Hepatitis C Virus ribonucleic acid (HCV RNA) 1000 IU/mL or greater
- Hepatitis C Virus (HCV) genotype 1
- End stage renal disease on hemodialysis
- Females of child bearing potential must be using an adequate method of contraception throughout the study and must have a negative pregnancy test prior to the start of treatment.
Exclusion Criteria:
- Intolerance to peg-IFN or ribavirin with prior treatment course.
- Prior treatment with protease inhibitor (telaprevir or boceprevir) or experimental protease inhibitor
Significant cytopenias:
- Absolute neutrophil count (ANC) < 1000/mm3, OR
- Hemoglobin (Hgb) <10.5 g/dL, or
- Platelet count < 50,000/mm3
Significant laboratory abnormalities
- Direct bilirubin > 1.5 x upper limit of normal (ULN)
- Total bilirubin > 1.6 mg/dL unless due to Gilbert's disease
- Prothrombin time (PT)/Partial thromboplastin time (PTT) > 10% above laboratory reference range
- Thyroid Stimulating Hormone (TSH) > 1.2 x ULN or < 0.8 x lower limit of normal (LLN)
- Uncontrolled depression or psychiatric disease
- Uncontrolled cardiopulmonary or cardiovascular disease
- Autoimmune diseases except for treated thyroid disease
- Active substance abuse within 6 months of initiation of treatment
- Recent (within 4 weeks) episode of infection requiring systemic antibiotics
- Any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation
- Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study
- Human immunodeficiency virus (HIV) or Hepatitis B Virus (HBV) co-infection
- Hepatocellular carcinoma (HCC) (Patients with HCC who are listed for liver transplantation may be included.)
- Other significant chronic liver disease diagnosis
- Evidence of decompensated liver disease
- Solid organ transplant recipient (Patients who have a history of renal transplant, and have experienced kidney graft loss, and are not on immunosuppression may be included.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1 - Response Guided Therapy
Group 2 - Fixed Duration Therapy
Treatment naive and documented relapsers : Subjects who have never been previously treated with P-IFN +/- ribavirin therapy and those who have documented relapse after P-IFN +/- ribavirin therapy. Subjects in group 1 will receive P-IFN alfa 2a or P-IFN alfa 2b and ribavirin for a 4 week lead-in followed by the addition of boceprevir. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24 treatment with be continued for a total duration of 28 to 48 weeks.Subjects will be followed through treatment and up to 24 weeks post treatment.
Partial/Null Responders /Undefined Previous Response, Compensated cirrhosis: Subjects who have compensated cirrhosis, and/or were previously treated with P-IFN +/- ribavirin without SVR (including partial responders, null responders, and those previously treated without adequate documentation of response). Subjects in Group 2 will all be assigned to fixed duration therapy.Patients will be treated with P-IFN alfa 2a or P-IFN alfa 2b and ribavirin for a 4 week lead-in followed by the addition of boceprevir for a total of 48 weeks of therapy. Subjects will be followed through treatment and up to 24 weeks post treatment.