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

February 6, 2014 updated by: Vertex Pharmaceuticals Incorporated

A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Universitario Austral
      • Buenos Aires, Argentina
        • ACLIRES Argentina SRL
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Downtown ID Clinic/University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • John Buhler Research Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
  • Puerto Rico
      • Santurce, Puerto Rico
        • Fundacion de Investigation de Diego
  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia PC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Sytem
    • Texas
      • Dallas, Texas, United States, 75203
        • The liver institute at Methodist hospital
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)
  • Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)
  • Plasma HCV RNA of 100,000 IU/ml
  • HIV 1 and HIV2 ab seronegative
  • Body Mass Index (BMI) ≤ 35 kg/m2 BMI
  • Treatment Naive subjects

Exclusion Criteria:

  • Contraindications to peginterferon or ribavirin therapy
  • Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score > 5
  • Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A
This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
Drug: VCH-222 or matching placebo
capsule, oral, 4 doses once daily or twice daily, 3 days
Other Names:
  • VCH-222 is also known as VX-222
Drug: VCH-222 or matching placebo
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
Other Names:
  • VCH-222 is also known as VX-222
Experimental: Part B
VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
Drug: VCH-222 or matching placebo
capsule, oral, 4 doses once daily or twice daily, 3 days
Other Names:
  • VCH-222 is also known as VX-222
Drug: VCH-222 or matching placebo
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
Other Names:
  • VCH-222 is also known as VX-222
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Time Frame: Daily for the first 3 days and at each study visit
Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Time Frame: Week 4 and Week 12
Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Time Frame: Study visits throughout part B
Study visits throughout part B

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
Time Frame: Study visits throughout Part A
Study visits throughout Part A
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Time Frame: Time points through Part B
Time points through Part B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

ViroChem Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCH-222-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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