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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Liver Institute of Virginia.
Recruitment status was:  Not yet recruiting
Merck Sharp & Dohme Corp.
Chronic Liver Disease Foundation
Information provided by (Responsible Party):
Liver Institute of Virginia Identifier:
First received: November 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
  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.

Condition Intervention Phase
Chronic Hepatitis C
End Stage Renal Disease
Drug: Ribavirin
Drug: Peginterferon
Drug: Boceprevir
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Liver Institute of Virginia:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.
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.
Other Name: Rebetol
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.
Other Name: PegIntron, Rebetol and Victrelis
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.
Other Name: Victralis

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic HCV defined by:
  • A history of a positive anti-HCV or HCV RNA for > 6 months or
  • A liver biopsy demonstrating at least portal fibrosis
  • HCV genotype 1
  • No prior treatment with any interferon or peginterferon preparation
  • ESRD undergoing hemodialysis for at least 6 months
  • Willingness not to conceive a child during treatment and for 6 months following discontinuation of treatment.

Exclusion Criteria:

  • Histologic evidence of cirrhosis
  • Any co-existent liver disease
  • A platelet count < 90,000
  • A total white blood cell (WBC) < 2.5
  • An absolute neutrophil count < 1.5
  • Hemoglobin < 11 gm/dl on Epoetin-alpha
  • Positive test for anti-HIV
  • Pregnancy of the patient or their intimate partner
  • Women who are breast feeding
  • Significant cardiovascular disease
  • History of suicide intent, severe depression requiring hospitalization or significant psychiatric disease
  • Malignancy within 5 years of enrollment except for squamous or basal cell skin cancer
  • Co-existent immune disorder such as lupus, rheumatoid as arthritis, colitis, Crohns disease, sarcoidosis, etc.
  • Any patient in the opinion of the investigator who would not be a satisfactory study candidate
  Contacts and Locations
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Please refer to this study by its identifier: NCT01731301

United States, Virginia
Liver Institute of Virginia
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Liver Institute of Virginia
Merck Sharp & Dohme Corp.
Chronic Liver Disease Foundation
Principal Investigator: Mitchell L Shiffman, MD Liver Institute of Virginia, Bon Secours Health System
  More Information

Responsible Party: Liver Institute of Virginia Identifier: NCT01731301     History of Changes
Other Study ID Numbers: LIV01 
Study First Received: November 16, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Liver Institute of Virginia:
Chronic hepatitis C
End stage renal disease
Triple therapy

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents processed this record on January 14, 2017