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The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid |
|
| Cohort 2 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid |
|
| Cohort 3 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANA598 200 mg bid or placebo | Drug | ANA598 200 mg bid or placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; | 10 days | |
| The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Missouri | St Louis | Missouri | 63104 | United States | ||
| United States, New York |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25456558 | Derived | Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4. |
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| ANA598 400 mg bid or placebo |
| Drug |
ANA598 400 mg bid or placebo |
|
| ANA598 800 mg bid or placebo | Drug | ANA598 800 mg bid or placebo |
|
| New York |
| New York |
| 10021 |
| United States |
| United States, Texas | San Antonio | Texas | 78215 | United States |
| Puerto Rico, Santurce | Santurce | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
|---|---|
| C000592794 | setrobuvir |
| C494814 | BID protein, human |
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