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NCT01080222 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT01080222 is a Phase 2 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 152 participants.
The verdict
NCT01080222, a Phase 2 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.
Interventions
- DRUG ribavirin
- DRUG telaprevir
- DRUG VX-222
- BIOLOGICAL peginterferon-alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01080222
The ClinicalTrials.gov registry entry for NCT01080222 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which ribavirin is the first listed.
NCT01080222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01080222 about?
NCT01080222 is a clinical study titled "A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection". The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 a...
What is the current status of trial NCT01080222?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2010-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01080222?
The interventions under investigation include: ribavirin (DRUG), telaprevir (DRUG), VX-222 (DRUG), peginterferon-alfa-2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT01080222?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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