Clinical trial NCT01731301: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis C
End Stage Renal Disease
Keywords: Chronic hepatitis C
HCV
End stage renal disease
ESRD
Boceprevir
Ribavirin
Peg-interferon
Triple therapy
Lead sponsor: Liver Institute of Virginia
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Chronic Liver Disease Foundation
First posted: 2012-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients who achieve eRVR at treatment week 28
timeFrame: 28 weeks
Secondary outcomes:
measure: Tolerability of treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Liver Institute of Virginia
state: Virginia
Study officials:
affiliation: Liver Institute of Virginia, Bon Secours Health System
name: Mitchell L Shiffman, MD
role: PRINCIPAL_INVESTIGATOR
References: