Status:
COMPLETED
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening.
- 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
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01856426
Start Date
June 1 2013
End Date
October 1 2015
Last Update
January 29 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigative Site
Miami, Florida, United States, 33169
2
Investigative Site
San Antonio, Texas, United States, 78215
3
Investigative Site
Murray, Utah, United States, 84123
4
Investigative Site
Frankfurt, Germany, 60590