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

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ClinicalTrials.gov Identifier: NCT01731301
Recruitment Status : Unknown
Verified November 2012 by Liver Institute of Virginia.
Recruitment status was:  Not yet recruiting
First Posted : November 21, 2012
Last Update Posted : November 22, 2012
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Chronic Liver Disease Foundation
Information provided by (Responsible Party):
Liver Institute of Virginia

Tracking Information
First Submitted Date  ICMJE November 16, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2012)
Percentage of patients who achieve eRVR at treatment week 28 [ Time Frame: 28 weeks ]
The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01731301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2012)
Tolerability of treatment [ Time Frame: 48 weeks ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • End Stage Renal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Ribavirin
  • Drug: Peginterferon
  • Drug: Boceprevir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 16, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01731301
Other Study ID Numbers  ICMJE LIV01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liver Institute of Virginia
Study Sponsor  ICMJE Liver Institute of Virginia
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Chronic Liver Disease Foundation
Investigators  ICMJE
Principal Investigator: Mitchell L Shiffman, MD Liver Institute of Virginia, Bon Secours Health System
PRS Account Liver Institute of Virginia
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP