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

This study is currently recruiting participants.
Verified December 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01856426
First received: May 14, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hepatitis C
Drug: EDP239
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline Hepatitis C viral load at Day 1 [ Time Frame: baseline, day 1 ] [ Designated as safety issue: No ]
    Blood will be collected for Hepatitis C viral load at Day 1.


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

  • Change from baseline in HCV RNA log [ Time Frame: baseline, Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, day 1 ] [ Designated as safety issue: No ]
    The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.


Estimated Enrollment: 28
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856426

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Florida
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33169
United States, Texas
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78215
United States, Utah
Novartis Investigative Site Not yet recruiting
Murray, Utah, United States, 84123
Germany
Novartis Investigative Site Not yet recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Not yet recruiting
Hamburg, Germany, 20099
Novartis Investigative Site Not yet recruiting
Hannover, Germany, 30625
Novartis Investigative Site Not yet recruiting
Köln, Germany, 50924
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01856426     History of Changes
Other Study ID Numbers: CEDP239X2201
Study First Received: May 14, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hepatitis C infected subjects

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014