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The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 week treatment | Experimental |
| |
| 16 week treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-222 | Drug | 400 mg tablets twice daily for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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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| telaprevir | Drug | 1125 mg tablets twice daily for oral administration |
|
|
| ribavirin | Drug | 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily |
|
|
| 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 |
| The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) | 48 weeks either after the last planned dose of study drug or after time of failure |
| The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT) | up to 16 weeks |
| Time to achieve <LLOQ undetectable HCV RNA | up to 16 weeks |
| The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT) | up to 16 weeks |
| The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12 | 12 weeks after the last planned dose of treatment |
| The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure | 48 weeks either after the last planned dose of study drug or after time of failure |
| Anaheim |
| California |
| United States |
| Riverside | California | United States |
| San Diego | California | United States |
| Englewood | Colorado | United States |
| Orlando | Florida | United States |
| Marietta | Georgia | United States |
| Baltimore | Maryland | United States |
| New York | New York | United States |
| Asheville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Pittsburgh | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| 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 |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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