Approval Probability
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VX-135 · 3 trials · 4 indications
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
| Arm | Type | Description |
|---|---|---|
| VX-135 low dose in combination with ribavirin | EXPERIMENTAL | 12 weeks of VX-135 in combination with ribavirin |
| VX-135 high dose in combination with ribavirin | EXPERIMENTAL | - |
| 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 |
| 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 |
|---|---|---|
| VX-135 | DRUG | 12 weeks of VX-135 |
| Ribavirin | DRUG | 12 weeks of ribavirin |
| Daclatasvir | DRUG | - |
Key Inclusion Criteria: * Subjects (male and female) must be between 18-60 years of age * Subjects must have Chronic Hepatitis C * Subjects must be treatment naive * Subjects must have laboratory values at screening within limits as specified by the protocol Key Exclusion Criteria: * Evidence of ...
VX-135 is an investigational small molecule developed for the treatment of chronic hepatitis C, a viral infection of the liver. It has been studied in Phase 2 clinical trials in treatment-naive patients with chronic hepatitis C, including genotype 1. It is not approved for any indication.
VX-135 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex sponsored the Phase 2 clinical program evaluating VX-135 in chronic hepatitis C, both as a single agent with ribavirin and in combination with daclatasvir.
VX-135 is in Phase 2 development. Three Phase 2 trials have been conducted in chronic hepatitis C, of which two are completed and none are currently active. The studies together enrolled 53 participants. VX-135 is investigational and has not been approved by the FDA.
VX-135 has been studied in three Phase 2 trials: NCT01842451, which evaluated VX-135 with daclatasvir in genotype 1 chronic hepatitis C in New Zealand; NCT01790100, a dose-ranging study with ribavirin in Moldova; and NCT01726946, which tested VX-135 with ribavirin in the United States.
The VX-135 Phase 2 program used randomized, double-blind, controlled designs. Trials combined VX-135 with ribavirin in treatment-naive chronic hepatitis C patients, and one trial paired it with daclatasvir in genotype 1 patients. Enrollment across the three completed studies totaled 53 participants aged 18 and older.