A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
NCT ID: NCT01731301
Last Updated: 2012-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2013-01-31
2015-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Chronic Liver Disease Foundation
OTHER
Liver Institute of Virginia
OTHER
Responsible Party
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Principal Investigators
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Mitchell L Shiffman, MD
Role: PRINCIPAL_INVESTIGATOR
Liver Institute of Virginia, Bon Secours Health System
Locations
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Liver Institute of Virginia
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Mitchell L Shiffman, MD
Role: primary
Other Identifiers
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LIV01
Identifier Type: -
Identifier Source: org_study_id