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Boceprevir in End Stage Renal Disease (ESRD)

NCT02112630 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-09-23

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and efficacy of triple therapy with pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).

Conditions

Interventions

DRUG

P-IFN alfa 2a

P-IFN alfa 2b 0.75 mcg/kg/week

DRUG

P-IFN alfa 2b

P-IFN alfa 2a 135 mcg/kg/week

DRUG

Ribavirin

200 mg PO once daily or 200 mg PO three times a week

DRUG

Boceprevir

800 mg PO three times daily starting at week 4

Sponsors & Collaborators

Principal Investigators

  • Elizabeth C Verna, MD, MS · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112630 on ClinicalTrials.gov