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NCT Number: NCT02593162

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

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.

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Key information

Conditions

Hepatitis C Viral Infection Blood-Borne Infections Chronic Disease Chronic Hepatitis C Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections HEPATITIS C (HCV) Hepatitis Hepatitis C Hepatitis C Genotype 4 Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern California Research Center

Coronado, California, 92118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faldaprevir

Drug

Other names: BI 201335

TD-6450

Drug

Ribavirin

Drug

Other names: Ribasphere®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Trek Therapeutics, PBC

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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