Boceprevir in ESRD

Prospective, Multi-Center, Open Label, Pilot Study of Safety and Efficacy of Triple Anti-Viral Therapy with Pegylated Interferon, Ribavirin, and Boceprevir in Patients with Genotype 1 Chronic HCV with End Stage Renal Disease

The purpose of the study is to assess the safety and efficacy of triple therapy with pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).

Trial Website: https://clinicaltrials.gov/show/NCT02112630

Are you Eligible? (Inclusion 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.)

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States