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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005633-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.
Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-135 | Drug | 12 weeks of VX-135 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The safety and tolerability as assessed by evaluating adverse events and laboratory testing. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| evidence of HCV RNA viral load reduction | The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) | 16 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia, Republican Clinical Hospital | Chisinau | Moldova |
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| Ribavirin | Drug | 12 weeks of ribavirin |
|
| 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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