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The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celgosivir | Drug | 400mg qd + standard of care for 12 weeks |
| |
| Celgosivir |
| Measure | Description | Time Frame |
|---|---|---|
| Safety analysis | 12 weeks | |
| HCV viral load | 12 weeks | |
| Pharmacokinetics of celgosivir/castanospermine | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jim Pankovich | Contact | 604-221-9666 | 259 |
| Name | Affiliation | Role |
|---|---|---|
| Jim Pankovich | BioWest Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and Intestinal Research Centre | Recruiting | Vancouver | British Columbia | V5Z 1H2 | Canada | |
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| Drug |
600mg qd + standard of care for 12 weeks |
|
| Peginterferon alfa 2b + ribavirin | Drug | Standard of care for 12 weeks |
|
| Cantest |
| Completed |
| Vancouver |
| British Columbia |
| V5Z 1H6 |
| Canada |
| Biovail Contract Research | Recruiting | Toronto | Ontario | M1L 4S4 | Canada |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C070715 | celgosivir |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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