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| Name | Class |
|---|---|
| ViroChem Pharma | INDUSTRY |
| Duke Clinical Research Institute | OTHER |
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The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | VCH-916 100 mg three times a day (t.i.d.) |
|
| Cohort 2 | Experimental | VCH-916 200 mg (t.i.d.) |
|
| Cohort 3 | Experimental | VCH-916 300 mg twice daily for three days |
|
| cohort 4 | Experimental | VCH-916 400 mg twice daily for three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCH 916 | Drug | Dose escalation study with a full review of all safety data following each cohort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection. | Day 1 to Day 17 visits |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. | Day 1 visit | |
| To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults. | Day 1 to Day 4 visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McHutchison, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Liver INstitute at Methodist Dallas | Dallas | Texas | 75208 | United States | ||
| Alamo Medical Research |
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| Placebo | Drug | Dose escalation study with a full review of all safety data following each cohort. |
|
| To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916. | Day 1 to Day 4 visits |
| San Antonio |
| Texas |
| 78215 |
| United States |
| Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Fundacion de Investigacion de Diego | Santurce | 00909 | 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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