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

NCT01731301 | Unknown Phase 4

• 1 other identifier: LIV01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis.
2. 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. 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.

Conditions

Chronic Hepatitis C; End Stage Renal Disease

Keywords

Chronic hepatitis C; HCV; End stage renal disease; ESRD; Boceprevir; Ribavirin; Peg-interferon; Triple therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  28 weeks

Secondary Outcomes (1)

• Tolerability of treatment

  48 weeks

Study Arms (1)

Ribavirin, peginterferon, boceprevir

EXPERIMENTAL

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; Drug: Peginterferon; Drug: Boceprevir

Interventions

Ribavirin DRUG

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.

Also known as: Rebetol

Ribavirin, peginterferon, boceprevir

Peginterferon DRUG

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.

Also known as: PegIntron, Rebetol and Victrelis

Ribavirin, peginterferon, boceprevir

Boceprevir DRUG

Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.

Also known as: Victralis

Ribavirin, peginterferon, boceprevir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liver Institute of Virginia: lead
• Merck Sharp & Dohme LLC: collaborator
• Chronic Liver Disease Foundation: collaborator

Study Sites (1)

Liver Institute of Virginia

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Kidney Failure, Chronic

Interventions

Ribavirin; peginterferon alfa-2b; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mitchell L Shiffman, MD

  Liver Institute of Virginia, Bon Secours Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell L Shiffman, MD

CONTACT

804-977-8920; mitchell_shiffman@bshsi.org

April G. Long, NP

CONTACT

804-977-8920; april_long@bshsi.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

US (1)