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Completed

NCT Number: NCT00911963

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ACLIRES Argentina SRL, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCH-222 or matching placebo

Drug

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

Other names: VCH-222 is also known as VX-222

peginterferon alfa-2a

Biological

subcutaneous injection, 180 μg, once weekly, 48 weeks

Ribavirin

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)

    Time frame: Time points through Part B

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Collaborators

  • ViroChem Pharma

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2009
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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