Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: EDP239; Drug: Placebo

• Registration Number: NCT01856426
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Study Start: 2013-06
• Primary Completion: 2014-11
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-EDP239	EDP239	EDP239 given once a day.
1- EDP239	EDP239	EDP239 given once a day.
2- EDP239	EDP239	EDP239 given once a day.
Placebo	Placebo	1 treatment arm will be placebo, dose given once a day.
4-EDP239	EDP239	EDP239 given once a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline Hepatitis C viral load at Day 1	baseline, day 1	Blood will be collected for Hepatitis C viral load at Day 1.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HCV RNA log	baseline, Day 1	A viral load drop in excess of 2.5 will be considered a success.
Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects	baseline, day 1	The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.
Number of participants with adverse events as a measure of safety	14 days	Laboratory and clinical evaluations will be used as safety events

Trial Locations

Locations (1)

Investigative Site; 🇩🇪 Hamburg, Germany