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An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Aspartate Aminotransferase (AST) elevation | measured by immunoassay | Up to 36 weeks |
| Incidence of Alanine Aminotransferase (ALT) elevation | measured by immunoassay | Up to 36 weeks |
| Incidence of Total Bilirubin (tBili) elevation | measured by immunoassay | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan | measured by adverse events | Up to 36 weeks |
| Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in Japan who are initiating treatment with DCV Trio therapy
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Tokyo | 1620814 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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measured by number of patients
| Up to 24 weeks |
| Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24) | measured by number of patients | Up to 36 weeks |
| Percentage of patients to experience virologic breakthrough | measured by percentage of patients | Up to 36 weeks |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |