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| Name | Class |
|---|---|
| ViroChem Pharma | INDUSTRY |
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The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.
The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | This will be a 4 dose escalation study comparing VCH-222 to placebo treatment. |
|
| Part B | Experimental | VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCH-222 or matching placebo | Drug | capsule, oral, 4 doses once daily or twice daily, 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A) | Daily for the first 3 days and at each study visit | |
| To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B) | Week 4 and Week 12 | |
| Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B) | Study visits throughout part B |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A) | Study visits throughout Part A | |
| To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B) | Time points through Part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Specialists of Georgia PC | Marietta | Georgia | 30060 | United States | ||
| Henry Ford Health Sytem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24982088 | Derived | Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30. |
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| VCH-222 or matching placebo | Drug | capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks |
|
|
| peginterferon alfa-2a | Biological | subcutaneous injection, 180 μg, once weekly, 48 weeks |
|
| ribavirin | Drug | tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks |
|
| Detroit |
| Michigan |
| 48202 |
| United States |
| The liver institute at Methodist hospital | Dallas | Texas | 75203 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| ACLIRES Argentina SRL | Buenos Aires | Argentina |
| Hospital Universitario Austral | Buenos Aires | Argentina |
| Downtown ID Clinic/University of British Columbia | Vancouver | British Columbia | V6Z 2C7 | Canada |
| John Buhler Research Centre | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Fundacion de Investigation de Diego | Santurce | Puerto Rico |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000592793 | lomibuvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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