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A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV

NCT01949168 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-09-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection.

Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection.

The investigators therefore hypothesise that:

i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.

ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets)

DRUG

Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection

DRUG

Rebetol® (ribavirin), 1000/1200mg by mouth daily

Sponsors & Collaborators

Principal Investigators

  • Alexander Thompson, MBBS · St Vincent's Hospital Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-09-30

Countries

  • Australia

Study Locations

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Entities

Companies

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 NCT01949168 on ClinicalTrials.gov