A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Recruitment status was Not yet recruiting
- A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis.
- 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.
- 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.
Chronic Hepatitis C
End Stage Renal Disease
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Percentage of patients who achieve eRVR at treatment week 28 [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
- Tolerability of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Ribavirin, peginterferon, boceprevir
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
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.
Other Name: RebetolDrug: 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.
Other Name: PegIntron, Rebetol and VictrelisDrug: 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.
Other Name: Victralis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731301
|Contact: Mitchell L Shiffman, MDfirstname.lastname@example.org|
|Contact: April G. Long, NPemail@example.com|
|United States, Virginia|
|Liver Institute of Virginia||Not yet recruiting|
|Richmond, Virginia, United States, 23226|
|Contact: Mitchell L Shiffman, MD 804-977-8920 firstname.lastname@example.org|
|Principal Investigator: Mitchell L Shiffman, MD|
|Principal Investigator:||Mitchell L Shiffman, MD||Liver Institute of Virginia, Bon Secours Health System|