Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
NCT ID: NCT01856426
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2013-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1- EDP239
EDP239 given once a day.
EDP239
Placebo
1 treatment arm will be placebo, dose given once a day.
Placebo
2- EDP239
EDP239 given once a day.
EDP239
3-EDP239
EDP239 given once a day.
EDP239
4-EDP239
EDP239 given once a day.
EDP239
Interventions
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EDP239
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subjects must have chronic HCV infection as determined by any of the following:
* be anti-HCV (+) for at least 6 months per subject history or medical records
* an anti-HCV test, viral load, or genotype \> 6 months ago
* In the setting of a recent positive anti-HCV test (\< 6 months), liver biopsy demonstrating chronicity
* Subjects must have IL-28b genotype "CC"
* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
Exclusion Criteria
* Previous treatment, including the use of any investigational agents, for the treatment of HCV infection.
* Women of child bearing potential.
* Subjects with IL-28b genotype "CT or TT".
* ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN).
* Serum bilirubin must not exceed ULN.
* The PT (INR) must be within normal limits.
* If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
* Use of drugs that inhibit or induce CYP3A4.
18 Years
60 Years
ALL
No
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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Investigative Site
Miami, Florida, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
Murray, Utah, United States
Investigative Site
Frankfurt, , Germany
Investigative Site
Hamburg, , Germany
Countries
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References
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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.
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.
Other Identifiers
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CEDP239X2201
Identifier Type: -
Identifier Source: org_study_id