Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
NCT ID: NCT00911963
Last Updated: 2014-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2009-04-30
2012-09-30
Brief Summary
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The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Part A
This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
VCH-222 or matching placebo
capsule, oral, 4 doses once daily or twice daily, 3 days
Part B
VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
VCH-222 or matching placebo
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
peginterferon alfa-2a
subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
Interventions
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VCH-222 or matching placebo
capsule, oral, 4 doses once daily or twice daily, 3 days
VCH-222 or matching placebo
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
peginterferon alfa-2a
subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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ViroChem Pharma
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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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
Countries
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References
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Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30.
Other Identifiers
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VCH-222-102
Identifier Type: -
Identifier Source: org_study_id
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