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The objective of this study is to assess the safety, tolerability and effectiveness of 8-week Glecaprevir/Pibrentasvir (G/P) in participants taking either prescribed or illicit drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir/Pibrentasvir | Data from participants prescribed Glecaprevir/pibrentasvir will be collected. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 210 days |
| Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN) | ALT and AST levels will be assessed. | Up to approximately 210 days |
| Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN | ALT, AST and Bilirubin levels will be assessed. | Up to approximately 210 days |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitri Semizarov | Contact | +1 847-935-8741 | dimitri.semizarov@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Infectious Diseases Centre /ID# 275313 | Recruiting | Vancouver | British Columbia | V6Z 2C7 | Canada | |
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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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| St. Clair Medical Clinic /ID# 275334 |
| Recruiting |
| Toronto |
| Ontario |
| M4S 1Y2 |
| Canada |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |