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The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- EDP239 | Experimental | EDP239 given once a day. |
|
| Placebo | Placebo Comparator | 1 treatment arm will be placebo, dose given once a day. |
|
| 2- EDP239 | Experimental | EDP239 given once a day. |
|
| 3-EDP239 | Experimental | EDP239 given once a day. |
|
| 4-EDP239 | Experimental | EDP239 given once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP239 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Hepatitis C viral load at Day 1 | Blood will be collected for Hepatitis C viral load at Day 1. | baseline, day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety | Laboratory and clinical evaluations will be used as safety events | 14 days |
| Change from baseline in HCV RNA log | A viral load drop in excess of 2.5 will be considered a success. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Miami | Florida | 33169 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27503644 | Derived | Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Wong KA, Jones CT, Jiang L, Lin K, Or YS. Preclinical and Clinical Resistance Profile of EDP-239, a Novel Hepatitis C Virus NS5A Inhibitor. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6216-26. doi: 10.1128/AAC.00815-16. Print 2016 Oct. | |
| 27503640 | Derived |
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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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| ID | Term |
|---|---|
| C000621307 | EDP-239 |
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| Drug |
|
| baseline, Day 1 |
| Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects | The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method. | baseline, day 1 |
| San Antonio |
| Texas |
| 78215 |
| United States |
| Investigative Site | Murray | Utah | 84123 | United States |
| Investigative Site | Frankfurt | 60590 | Germany |
| Investigative Site | Hamburg | 20099 | Germany |
| Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Peng X, Wang C, Ying L, Cao H, Lawitz E, Poordad F, Rondon J, Box TD, Zeuzem S, Buggisch P, Lin K, Qiu YL, Jiang L, Colvin R, Or YS. Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6207-15. doi: 10.1128/AAC.00808-16. Print 2016 Oct. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |