Clinical trial NCT02593162: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Viral Infection
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 4
Lead sponsor: Trek Therapeutics, PBC
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Post Treatment Week 12
Secondary outcomes:
measure: 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)
timeFrame: Week 12
measure: 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)
timeFrame: Post Treatment Weeks 2 to 8
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Research Center
state: California
Study officials:
affiliation: Southern California Research Center
name: Tarek Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
References: