An interventional study of P-IFN alfa 2a and P-IFN alfa 2b in Hepatitis C Infection and End Stage Renal Disease, sponsored by Columbia University. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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).
Hepatitis C (HCV) remains the most common chronic infection in the United States with about 3 million people chronically infected. The majority of these patients in the U.S. have genotype 1 HCV infection, which has been the most difficult genotype to treat with the traditional regimen of pegylated-interferon (P-IFN) and ribavirin, leading to sustained virologic response (SVR) in less than 50% of cases. HCV is also an established risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD) and unfortunately the treatment is even less successful in these patients mainly limited by increased medication toxicity.
In spring of 2011, the FDA approved two new direct acting antivirals (DAA) for the treatment of chronic genotype 1 HCV, boceprevir and telaprevir, to be used in combination with Peg-IFN and ribavirin. This 'triple therapy' approach has significantly increased the response rate (increased SVR rates to about 80% in those patients who had never been previously treated) representing a significant advance in the field. In addition, several response-guided therapy approaches were tested to determine if treatment duration could be shortened based upon the virologic response on treatment.
To date, there have been no studies evaluating the safety and efficacy of triple therapy in patients with ESRD. However, a single dose pharmacokinetic study of boceprevir in subjects with ESRD on hemodialysis demonstrated that the mean maximum concentration achieved by boceprevir (Cmax) and bioavailability (AUC) were comparable in patients with ESRD and in healthy subjects. Mean t½, median Tmax and mean apparent oral total clearance (CL/F) values were also similar in healthy subjects and patients with ESRD. Boceprevir exposure was also similar on dialysis and non-dialysis days. These data suggest that boceprevir does not need to be adjusted in patients with ESRD on dialysis, and that it is not removed by hemodialysis. To date, there are no studies of telaprevir in ESRD patients.
The investigators therefore aim to study the safety and efficacy of triple therapy using boceprevir in combination with P-IFN and ribavirin in patients with stage 5 CKD (defined as glomerular filtration rate (GFR) \< 15 mL.min.1.73m2 on permanent hemodialysis for stage 5). In addition, given the significant toxicity of treatment in this particular patient population, the investigators aim to study the efficacy of response guided therapy in those patients who are eligible for response-guided therapy based on prior studies (treatment naïve patients, and well documented history of relapse with prior treatment with P-IFN and ribavirin).
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
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Exclusion Criteria:
Significant cytopenias:
Significant laboratory abnormalities
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.
Drug: P-IFN alfa 2a · Drug: P-IFN alfa 2b · Drug: Ribavirin · Drug: Boceprevir
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.
Drug: P-IFN alfa 2a · Drug: P-IFN alfa 2b · Drug: Ribavirin · Drug: Boceprevir
P-IFN alfa 2b 0.75 mcg/kg/week
Also known as: Pegylated-interferon alfa 2a
P-IFN alfa 2a 135 mcg/kg/week
Also known as: Pegylated-interferon alfa 2b
200 mg PO once daily or 200 mg PO three times a week
Also known as: Copegus®
800 mg PO three times daily starting at week 4
Also known as: Victrelis
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).
Time frame: Up to 12 weeks after discontinuation of all therapy
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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