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)
Liver
Trial Location
NYP/Columbia
New York, NY 10032
United States