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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00911963

Run by

Vertex Pharmaceuticals Incorporated

People needed

49

Starts

2009-04-01

Expected to finish

2012-09-01

Last updated by the study team

2014-03-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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