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

Primary Purpose

Chronic Hepatitis C, End Stage Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ribavirin
Peginterferon
Boceprevir
Sponsored by
Liver Institute of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, HCV, End stage renal disease, ESRD, Boceprevir, Ribavirin, Peg-interferon, Triple therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liver Institute of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ribavirin, peginterferon, boceprevir

Arm Description

The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.

Outcomes

Primary Outcome Measures

Percentage of patients who achieve eRVR at treatment week 28
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
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

Full Information

First Posted
November 16, 2012
Last Updated
November 20, 2012
Sponsor
Liver Institute of Virginia
Collaborators
Merck Sharp & Dohme LLC, Chronic Liver Disease Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01731301
Brief Title
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liver Institute of Virginia
Collaborators
Merck Sharp & Dohme LLC, Chronic Liver Disease Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, End Stage Renal Disease
Keywords
Chronic hepatitis C, HCV, End stage renal disease, ESRD, Boceprevir, Ribavirin, Peg-interferon, Triple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribavirin, peginterferon, boceprevir
Arm Type
Experimental
Arm Description
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Rebetol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon
Other Intervention Name(s)
PegIntron, Rebetol and Victrelis
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
Victralis
Intervention Description
Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.
Primary Outcome Measure Information:
Title
Percentage of patients who achieve eRVR at treatment week 28
Description
The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Tolerability of treatment
Description
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
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell L Shiffman, MD
Phone
804-977-8920
Email
mitchell_shiffman@bshsi.org
First Name & Middle Initial & Last Name or Official Title & Degree
April G. Long, NP
Phone
804-977-8920
Email
april_long@bshsi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell L Shiffman, MD
Organizational Affiliation
Liver Institute of Virginia, Bon Secours Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell L Shiffman, MD
Phone
804-977-8920
Email
mitchell_shiffman@bshsi.org
First Name & Middle Initial & Last Name & Degree
Mitchell L Shiffman, MD

12. IPD Sharing Statement

Learn more about this trial

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

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