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Trial record 20 of 20 for:    Genotype 1 | BI 201335 OR faldaprevir

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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Viral Infection Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 4 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

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

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

Experimental: Group 2
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Drug: Faldaprevir
Other Name: BI 201335

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02593162


Locations
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United States, California
Southern California Research Center
Coronado, California, United States, 92118
Sponsors and Collaborators
Trek Therapeutics, PBC
Investigators
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Principal Investigator: Tarek Hassanein, MD Southern California Research Center

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Responsible Party: Trek Therapeutics, PBC
ClinicalTrials.gov Identifier: NCT02593162     History of Changes
Other Study ID Numbers: TRK-450-0201
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents