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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856426
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Enanta Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: EDP239 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1- EDP239
EDP239 given once a day.
Drug: EDP239
Placebo Comparator: Placebo
1 treatment arm will be placebo, dose given once a day.
Drug: Placebo
Experimental: 2- EDP239
EDP239 given once a day.
Drug: EDP239
Experimental: 3-EDP239
EDP239 given once a day.
Drug: EDP239
Experimental: 4-EDP239
EDP239 given once a day.
Drug: EDP239

Primary Outcome Measures :
  1. Change from baseline Hepatitis C viral load at Day 1 [ Time Frame: baseline, day 1 ]
    Blood will be collected for Hepatitis C viral load at Day 1.

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety [ Time Frame: 14 days ]
    Laboratory and clinical evaluations will be used as safety events

  2. Change from baseline in HCV RNA log [ Time Frame: baseline, Day 1 ]
    A viral load drop in excess of 2.5 will be considered a success.

  3. Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects [ Time Frame: baseline, day 1 ]
    The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856426

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United States, Florida
Investigative Site
Miami, Florida, United States, 33169
United States, Texas
Investigative Site
San Antonio, Texas, United States, 78215
United States, Utah
Investigative Site
Murray, Utah, United States, 84123
Investigative Site
Frankfurt, Germany, 60590
Investigative Site
Hamburg, Germany, 20099
Sponsors and Collaborators
Enanta Pharmaceuticals
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Study Director: Enanta Pharmaceuticals Enanta Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Enanta Pharmaceuticals Identifier: NCT01856426    
Other Study ID Numbers: CEDP239X2201
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by Enanta Pharmaceuticals:
Hepatitis C infected subjects
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections