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A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-135 High Dose with Daclatasvir | Experimental | 12 weeks of a high dose of VX-135 in combination with Daclatasvir |
|
| VX-135 Low Dose with Daclatasvir | Experimental | 12 weeks of a low dose of VX-135 in combination with Daclatasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-135 | Drug |
| ||
| Daclatasvir |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments | Up to 64 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4) | Up to 20 Weeks | |
| The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand | Auckland | New Zealand | ||||
| New Zealand |
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| Drug |
|
| Up to 28 weeks |
| The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24) | Up to 40 weeks |
| The proportion of subjects who have virologic relapse | Up to 64 weeks |
| The proportion of subjects who have virologic breakthrough | Up to 16 weeks |
| The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure | Up to 64 weeks |
| The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a) | Up to 28 weeks |
| The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) | Up to 28 weeks |
| Christchurch |
| New Zealand |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C549273 | daclatasvir |
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