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Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection

NCT00911963 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-03-10

No results posted yet for this study

Summary

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.

The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.

Conditions

  • Hepatitis C

Interventions

DRUG

VCH-222 or matching placebo

capsule, oral, 4 doses once daily or twice daily, 3 days

DRUG

VCH-222 or matching placebo

capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks

BIOLOGICAL

peginterferon alfa-2a

subcutaneous injection, 180 μg, once weekly, 48 weeks

DRUG

ribavirin

tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Argentina
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

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 NCT00911963 on ClinicalTrials.gov