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A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

Primary Purpose

Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Faldaprevir
TD-6450
Ribavirin
Sponsored by
Trek Therapeutics, PBC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Viral Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening
  • Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening

  • Absence of cirrhosis as defined by one of the following:

    • A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis
    • Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa
    • A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening

Exclusion Criteria:

  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2

Sites / Locations

  • Southern California Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin

12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin

Outcomes

Primary Outcome Measures

Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults

Secondary Outcome Measures

Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin)
Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin)

Full Information

First Posted
October 29, 2015
Last Updated
January 27, 2017
Sponsor
Trek Therapeutics, PBC
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1. Study Identification

Unique Protocol Identification Number
NCT02593162
Brief Title
A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection
Official Title
Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trek Therapeutics, PBC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.
Detailed Description
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C infection. The study will test the safety and effects of this alternative treatment for up to 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
Arm Title
Group 2
Arm Type
Experimental
Arm Description
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Intervention Type
Drug
Intervention Name(s)
Faldaprevir
Other Intervention Name(s)
BI 201335
Intervention Type
Drug
Intervention Name(s)
TD-6450
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere®
Primary Outcome Measure Information:
Title
Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults
Time Frame
Post Treatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin)
Time Frame
Week 12
Title
Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin)
Time Frame
Post Treatment Weeks 2 to 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening Absence of cirrhosis as defined by one of the following: A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening Exclusion Criteria: Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Organizational Affiliation
Southern California Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

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