NCT01856426

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

May 14, 2013

Last Update Submit

January 28, 2016

Conditions

Hepatitis C

Keywords

Hepatitis C infected subjects

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of participants with adverse events as a measure of safety

    14 days

  • Change from baseline in HCV RNA log

    baseline, Day 1

  • Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects

    baseline, day 1

Study Arms (5)

1- EDP239

EXPERIMENTAL

EDP239 given once a day.

Drug: EDP239

Placebo

PLACEBO COMPARATOR

1 treatment arm will be placebo, dose given once a day.

Drug: Placebo

2- EDP239

EXPERIMENTAL

EDP239 given once a day.

Drug: EDP239

3-EDP239

EXPERIMENTAL

EDP239 given once a day.

Drug: EDP239

4-EDP239

EXPERIMENTAL

EDP239 given once a day.

Drug: EDP239

Interventions

EDP239DRUG
1- EDP2392- EDP2393-EDP2394-EDP239
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigative Site

Miami, Florida, 33169, United States

Location

Investigative Site

San Antonio, Texas, 78215, United States

Location

Investigative Site

Murray, Utah, 84123, United States

Location

Investigative Site

Frankfurt, 60590, Germany

Location

Investigative Site

Hamburg, 20099, Germany

Location

Related Publications (2)

  • Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Wong KA, Jones CT, Jiang L, Lin K, Or YS. Preclinical and Clinical Resistance Profile of EDP-239, a Novel Hepatitis C Virus NS5A Inhibitor. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6216-26. doi: 10.1128/AAC.00815-16. Print 2016 Oct.

    PMID: 27503644DERIVED

  • Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Peng X, Wang C, Ying L, Cao H, Lawitz E, Poordad F, Rondon J, Box TD, Zeuzem S, Buggisch P, Lin K, Qiu YL, Jiang L, Colvin R, Or YS. Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6207-15. doi: 10.1128/AAC.00808-16. Print 2016 Oct.

    PMID: 27503640DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

EDP-239

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Enanta Pharmaceuticals

    Enanta Pharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 17, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2014

Study Completion

October 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

US(3)DE(2)