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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716428
• Other study ID #: TRK-450-0203
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2016
• Last updated: October 13, 2017
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: Trek Therapeutics, PBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C (HCV)
• Hepatitis C Genotype 1
• Hepatitis C Viral Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• Faldaprevir

• TD-6450

• Ribavirin

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies	Auckland
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Waikato
United States	Bach and Godofsky Infectious Diseases	Bradenton	Florida
United States	Southern California Research Center	Coronado	California
United States	Gastro One	Germantown	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Trek Therapeutics, PBC

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Post Treatment Week 12
Secondary	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)		Post Treatment Weeks 2 to 8
Secondary	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		Randomization through End of Study, up to 24 weeks