A Phase 1/2 interventional study of VCH-222 or matching placebo and VCH-222 or matching placebo in Hepatitis C, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 10 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-10.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1/2, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
Drug: VCH-222 or matching placebo
VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
Drug: VCH-222 or matching placebo · Biological: peginterferon alfa-2a · Drug: ribavirin
capsule, oral, 4 doses once daily or twice daily, 3 days
Also known as: VCH-222 is also known as VX-222
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
Also known as: VCH-222 is also known as VX-222
subcutaneous injection, 180 μg, once weekly, 48 weeks
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
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
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
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
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
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Time frame: Time points through Part B
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated