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A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection

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: NCT02716428
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):
Trek Therapeutics, PBC

Brief Summary:
Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Viral Infection Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1 Drug: Faldaprevir Drug: TD-6450 Drug: Ribavirin Phase 2

Detailed Description:
A study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus
Actual Study Start Date : May 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Cohort 1
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
Drug: Faldaprevir
Other Name: BI 201335

Drug: TD-6450
Drug: Ribavirin
Other Name: Ribasphere®

Experimental: Cohort 2
12 weeks of Faldaprevir plus TD-6450
Drug: Faldaprevir
Other Name: BI 201335

Drug: TD-6450

Primary Outcome Measures :
  1. Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals with and without ribavirin in Genotype 1b Hepatitis C infected adults [ Time Frame: Post Treatment Week 12 ]

Secondary Outcome Measures :
  1. 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 with and without ribavirin) [ Time Frame: Post Treatment Weeks 2 to 8 ]
  2. Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events [ Time Frame: Randomization through End of Study, up to 24 weeks ]

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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic genotype 1b 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 (kilopascals)
    • A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST (aspartate aminotransferase):platelet ratio (APRI) ≤ 1 performed during screening

Exclusion Criteria:

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

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): NCT02716428

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United States, California
Southern California Research Center
Coronado, California, United States, 92118
United States, Florida
Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States, 34209
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
New Zealand
Auckland Clinical Studies
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Waikato, New Zealand
Sponsors and Collaborators
Trek Therapeutics, PBC
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Principal Investigator: Ed Gane, MD Auckland Clinical Studies Ltd
Principal Investigator: Tarek Hassanein, MD Southern California Research Center
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Responsible Party: Trek Therapeutics, PBC Identifier: NCT02716428    
Other Study ID Numbers: TRK-450-0203
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents