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

November 20, 2012 updated by: Liver Institute of Virginia

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Liver Institute of Virginia
        • Contact:
        • Principal Investigator:
          • Mitchell L Shiffman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Victralis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liver Institute of Virginia

Collaborators

Merck Sharp & Dohme LLC
Chronic Liver Disease Foundation

Investigators

  • Principal Investigator: Mitchell L Shiffman, MD, Liver Institute of Virginia, Bon Secours Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

January 1, 2015

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (ESTIMATE)

November 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 20, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIV01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe