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VX-222

Phase 2

Chronic Hepatitis C Virus | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Oct 20, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment167

FDA Designations

No designations recorded

Clinical trial landscape

VX-222 · 2 trials · 1 indication

Phase 2 2
NCT01581138VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis CChronic Hepatitis C Virus
COMPLETED64 Analytics
NCT01516918A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated CirrhosisChronic Hepatitis C Virus
COMPLETED103 Analytics
PHASE2COMPLETED
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Chronic Hepatitis C VirusUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Chronic Hepatitis C VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
12 weeks after the last planned dose of treatment
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
12 weeks

Secondary Endpoints

The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
4 weeks after the last planned dose of the study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
12 week treatmentEXPERIMENTAL -
16 week treatmentEXPERIMENTAL -
Quadruple RegimenEXPERIMENTALAll subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.

Interventions

NameTypeDescription
VX-222DRUG400 mg tablets twice daily for oral administration
telaprevirDRUG1125 mg tablets twice daily for oral administration
ribavirinDRUG1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
peginterferon-alfa-2aBIOLOGICALsubcutaneous injection, 180-mcg, once weekly
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit * Subjects will be treatment naïve * Subjects must have documentation of the presence or absence of cirrhosis Exclusion Criteria: ...

Countries:United StatesCanadaGermanyPolandUnited Kingdom
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Frequently asked questions about VX-222

What is VX-222 used for in chronic hepatitis C virus?

VX-222 is an investigational small molecule being studied for the treatment of chronic hepatitis C virus infection. It was evaluated in Phase 2 clinical trials in combination with other antiviral agents, including telaprevir, peginterferon-alfa-2a, and ribavirin, in patients with chronic hepatitis C, including those with compensated cirrhosis.

Who makes VX-222?

VX-222 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company conducted Phase 2 clinical trials of VX-222 in patients with chronic hepatitis C virus infection.

What phase is VX-222 in?

VX-222 is in Phase 2 clinical development. It has completed two Phase 2 trials, both of which are finished, and no active trials are currently listed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is VX-222 in?

VX-222 has been studied in two completed Phase 2 clinical trials. The first, NCT01516918, evaluated quadruple therapy with VX-222, telaprevir, peginterferon-alfa-2a, and ribavirin in 103 patients with chronic hepatitis C and compensated cirrhosis. The second, NCT01581138, studied VX-222 plus telaprevir and ribavirin for 12 or 16 weeks in 64 treatment-naive patients with genotype 1a hepatitis C.

Is VX-222 the same as telaprevir?

No, VX-222 is not the same as telaprevir. VX-222 is a separate investigational drug developed by Vertex Pharmaceuticals. In clinical trials, VX-222 was studied in combination with telaprevir, which is a different antiviral agent, along with peginterferon-alfa-2a and ribavirin, for the treatment of chronic hepatitis C virus infection.