End Stage Renal Disease Clinical Trial
Official title:
Prospective, Single-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
Verified date | September 2015 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Adult (ages 18-75) 2. Hepatitis C Virus ribonucleic acid (HCV RNA) 1000 IU/mL or greater 3. Hepatitis C Virus (HCV) genotype 1 4. End stage renal disease on hemodialysis 5. 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: 1. Intolerance to peg-IFN or ribavirin with prior treatment course. 2. Prior treatment with protease inhibitor (telaprevir or boceprevir) or experimental protease inhibitor 3. Significant cytopenias: 1. Absolute neutrophil count (ANC) < 1000/mm3, OR 2. Hemoglobin (Hgb) <10.5 g/dL, or 3. Platelet count < 50,000/mm3 4. Significant laboratory abnormalities 1. Direct bilirubin > 1.5 x upper limit of normal (ULN) 2. Total bilirubin > 1.6 mg/dL unless due to Gilbert's disease 3. Prothrombin time (PT)/Partial thromboplastin time (PTT) > 10% above laboratory reference range 4. Thyroid Stimulating Hormone (TSH) > 1.2 x ULN or < 0.8 x lower limit of normal (LLN) 5. Uncontrolled depression or psychiatric disease 6. Uncontrolled cardiopulmonary or cardiovascular disease 7. Autoimmune diseases except for treated thyroid disease 8. Active substance abuse within 6 months of initiation of treatment 9. Recent (within 4 weeks) episode of infection requiring systemic antibiotics 10. Any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation 11. Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study 12. Human immunodeficiency virus (HIV) or Hepatitis B Virus (HBV) co-infection 13. Hepatocellular carcinoma (HCC) (Patients with HCC who are listed for liver transplantation may be included.) 14. Other significant chronic liver disease diagnosis 15. Evidence of decompensated liver disease 16. 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.) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who achieve sustained virologic response | Primary efficacy is the proportion of patients who achieve sustained virologic response at week 12 after discontinuation of all therapy (SVR12). | Up to 12 weeks after discontinuation of all therapy | No |
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