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This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHC patients in Mexico | patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Adverse Events by Age | Approximately 24 months | |
| Distribution of Adverse Events by Gender | Approximately 24 months | |
| Distribution of Adverse Events by Interruption or Switch of Medication |
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Inclusion Criteria:
1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.
Exclusion Criteria:
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Patients with chronic Hepatitis C who are being given daclatasvir for the treatment and cure of chronic Hepatitis C at the sentinel sites for the CNFV in Mexico. Patients will be treated according to the clinical judgment of the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Benito Juárez | Mexico City | 03900 | Mexico | ||
| Local Institution |
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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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| Approximately 24 months |
| Distribution of Adverse Events by Concomitant Medication | Approximately 24 months |
| Distribution of Adverse Events by Race | Approximately 24 months |
| Mexico City |
| Mexico City |
| 14050 |
| Mexico |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |