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A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-135 High Dose with ribavirin | Experimental | 12 weeks of a high dose of VX-135 in combination with ribavirin |
|
| VX-135 Low Dose with ribavirin | Experimental | 12 weeks of a low dose of VX-135 in combination with ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-135 | Drug | 12 weeks of VX-135 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) | 16 weeks | |
| The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) | 24 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California | La Jolla | California | United States | |||
| Florida |
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| ribavirin | Drug | 12 weeks of ribavirin |
|
| The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) | 36 weeks |
| The proportion of subjects who have virologic relapse | Up to 52 weeks |
| Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA | Up to 64 weeks |
| The proportion of subjects who have virologic breakthrough | as measured by on-treatment HCV RNA values | Up to 52 weeks |
| The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) | up to 28 weeks |
| The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment | Up to 60 weeks |
| Orlando |
| Florida |
| United States |
| Georgia | Marietta | Georgia | United States |
| Tennessee | Germantown | Tennessee | United States |
| Texas | Arlington | Texas | United States |
| Texas | Houston | Texas | 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 |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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