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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Experimental | Treatment Arm A was discontinued as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. |
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| Treatment Arm B | Experimental | Treatment Arm B was discontinued as a result of patients meeting a pre-defined stopping rule relating to viral breakthrough. |
|
| Treatment Arm C | Experimental |
|
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| Treatment Arm D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir | Drug | tablet, 1125-mg, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Assessed by adverse events, physical examinations, vital signs, 12 lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (clinical chemistry, hematology, and urinalysis) | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieve a Sustained Viral Response | 24 weeks after the completion of the last dose of the assigned study drug treatment regimen | |
| Undetectable HCV RNA Measurements |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24982088 | Derived | 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. | |
| 24901821 |
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| Treatment Arm E | Experimental |
|
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| Treatment Arm F | Experimental |
|
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| VX-222 | Drug | capsule, 100-mg, twice daily |
|
| ribavirin | Drug | tablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily |
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| peginterferon-alfa-2a | Biological | subcutaneous injection, 180-mcg, once weekly |
|
| VX-222 | Drug | capsule, 400-mg, twice daily |
|
| 36 weeks |
| Proportion of Subjects Who Have a Viral Breakthrough or Relapse | 60 weeks |
| Plasma Exposures of VX-222 and Telaprevir | 12 weeks |
| San Francisco |
| California |
| United States |
| Aurora | Colorado | United States |
| Gainesville | Florida | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Lutherville | Maryland | United States |
| Rochester | Minnesota | United States |
| St Louis | Missouri | United States |
| Egg Harbor | New Jersey | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Durham | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Providence | Rhode Island | United States |
| Germantown | Tennessee | United States |
| Arlington | Texas | United States |
| San Antonio | Texas | United States |
| Falls Church | Virginia | United States |
| Auckland | New Zealand |
| Christchurch | New Zealand |
| Derived |
| Di Bisceglie AM, Sulkowski M, Gane E, Jacobson IM, Nelson D, DeSouza C, Alves K, George S, Kieffer T, Zhang EZ, Kauffman R, Asmal M, Koziel MJ. VX-222, a non-nucleoside NS5B polymerase inhibitor, in telaprevir-based regimens for genotype 1 hepatitis C virus infection. Eur J Gastroenterol Hepatol. 2014 Jul;26(7):761-73. doi: 10.1097/MEG.0000000000000084. |
| ID | Term |
|---|---|
| C486464 | telaprevir |
| C000592793 | lomibuvir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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