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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Liver Institute of Virginia
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Chronic Liver Disease Foundation
Information provided by (Responsible Party):
Liver Institute of Virginia
ClinicalTrials.gov Identifier:
NCT01731301
First received: November 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose
  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731301

Contacts
Contact: Mitchell L Shiffman, MD 804-977-8920 mitchell_shiffman@bshsi.org
Contact: April G. Long, NP 804-977-8920 april_long@bshsi.org

Locations
United States, Virginia
Liver Institute of Virginia Not yet recruiting
Richmond, Virginia, United States, 23226
Contact: Mitchell L Shiffman, MD    804-977-8920    mitchell_shiffman@bshsi.org   
Principal Investigator: Mitchell L Shiffman, MD         
Sponsors and Collaborators
Liver Institute of Virginia
Merck Sharp & Dohme Corp.
Chronic Liver Disease Foundation
Investigators
Principal Investigator: Mitchell L Shiffman, MD Liver Institute of Virginia, Bon Secours Health System
  More Information

No publications provided

Responsible Party: Liver Institute of Virginia
ClinicalTrials.gov 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
HCV
End stage renal disease
ESRD
Boceprevir
Ribavirin
Peg-interferon
Triple therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Kidney Diseases
Kidney Failure, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014