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

Hepatitis C Clinical Trial

Official title:

Double-Blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of Single Doses of EDP239 in Hepatitis C Virus (HCV) Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856426
• Other study ID #: CEDP239X2201
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2013
• Last updated: January 28, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 ?-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• EDP239

• Placebo

Locations

Country	Name	City	State
Germany	Investigative Site	Frankfurt
Germany	Investigative Site	Hamburg
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Murray	Utah
United States	Investigative Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse events as a measure of safety	Laboratory and clinical evaluations will be used as safety events	14 days	Yes
Secondary	Change from baseline in HCV RNA log	A viral load drop in excess of 2.5 will be considered a success.	baseline, Day 1	No
Secondary	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	No