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The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadruple Regimen | Experimental | All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-222 | Drug | tablet, 400-mg twice daily |
| |
| telaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. | up to 48 weeks | |
| The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) | 24 weeks |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Drug |
tablet, 1125-mg twice daily |
|
|
| ribavirin | Drug | tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily |
|
|
| peginterferon-alfa-2a | Biological | subcutaneous injection, 180-mcg, once weekly |
|
|
| The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment | up to week 12 |
| The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment | up to 48 weeks |
| The association of the IL-28B genotype with SVR12 | Proportion of subjects who have SVR12 by IL-28B genotype | 12 weeks |
| The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure | The identity and observed frequency of viral variants as compared to wild-type virus will be measured. | After the last planned dose of study drug or after time of failure |
| VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations | 12 weeks |
| San Diego |
| California |
| United States |
| Englewood | Colorado | United States |
| Bradenton | Florida | United States |
| Jacksonville | Florida | United States |
| Tampa | Florida | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Lebanon | New Hampshire | United States |
| Egg Harbor | New Jersey | United States |
| Manhasset | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Asheville | North Carolina | United States |
| Charlotte | 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 |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Vancouver | British Columbia | Canada |
| London | Ontario | Canada |
| Montreal | Quebec | Canada |
| Cologne | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| Hessen | Germany |
| Saschen | Germany |
| Stuttgart | Germany |
| Bialystok | Poland |
| Mysłowice | Poland |
| Wroclaw | Poland |
| London | United Kingdom |
| Plymouth | United Kingdom |
| Scotland | United Kingdom |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000592793 | lomibuvir |
| C486464 | telaprevir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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