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

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ClinicalTrials.gov Identifier: NCT02593162
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Trek Therapeutics, PBC

Tracking Information
First Submitted Date  ICMJE October 29, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date January 30, 2017
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02593162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C Viral Infection
  • Chronic Hepatitis C
  • Hepatitis C (HCV)
  • Hepatitis C Genotype 4
Intervention  ICMJE
  • Drug: Faldaprevir
    Other Name: BI 201335
  • Drug: TD-6450
  • Drug: Ribavirin
    Other Name: Ribasphere®
Study Arms  ICMJE
  • Experimental: Group 1
    12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
    Interventions:
    • Drug: Faldaprevir
    • Drug: TD-6450
    • Drug: Ribavirin
  • Experimental: Group 2
    12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
    Interventions:
    • Drug: Faldaprevir
    • Drug: TD-6450
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2015)
24
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593162
Other Study ID Numbers  ICMJE TRK-450-0201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Trek Therapeutics, PBC
Study Sponsor  ICMJE Trek Therapeutics, PBC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tarek Hassanein, MD Southern California Research Center
PRS Account Trek Therapeutics, PBC
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP