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Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

NCT02113631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-03-15

No results posted yet for this study

Summary

1. The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population.
2. The secondary objective:

* Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

Conditions

  • Hepatitis C, Chronic
  • Cirrhosis

Interventions

DRUG

Telaprevir

DRUG

Boceprevir

DRUG

Peg-IFN

Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks

DRUG

Ribavirin

Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks

Sponsors & Collaborators

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Yngve Falck-Ytter, MD · Louis Stokes Cleveland VA medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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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 NCT02113631 on ClinicalTrials.gov