Clinical trial NCT02716428: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Viral Infection
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Lead sponsor: Trek Therapeutics, PBC
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Post Treatment Week 12
Secondary outcomes:
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 with and without ribavirin)
timeFrame: Post Treatment Weeks 2 to 8
measure: 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
timeFrame: Randomization through End of Study, up to 24 weeks
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Bradenton
country: United States
facility: Bach and Godofsky Infectious Diseases
state: Florida
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Waikato
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Auckland Clinical Studies Ltd
name: Ed Gane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California Research Center
name: Tarek Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
References: