NCT01731301

A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Liver Institute of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. 3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

Detailed description

Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.

Conditions

• Chronic Hepatitis C
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Ribavirin	Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.
DRUG	Peginterferon	After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.
DRUG	Boceprevir	Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2015-01-01
• First posted: 2012-11-21
• Last updated: 2012-11-22

Locations

1 site across 1 country: United States