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

Sponsor

Trek Therapeutics, PBC (Industry)

Overall Status

Completed

CT.gov ID

NCT02716428

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

4.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Viral Infection Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1	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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 12 weeks of Faldaprevir plus TD-6450 plus Ribavirin	Drug: Faldaprevir Other Names: BI 201335 Drug: TD-6450 Drug: Ribavirin Other Names: Ribasphere®
Experimental: Cohort 2 12 weeks of Faldaprevir plus TD-6450	Drug: Faldaprevir Other Names: BI 201335 Drug: TD-6450

Arm

Intervention/Treatment

Experimental: Cohort 1

12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Drug: Faldaprevir

Other Names:

BI 201335

Drug: TD-6450

Drug: Ribavirin

Other Names:

Ribasphere®

Experimental: Cohort 2

12 weeks of Faldaprevir plus TD-6450

Drug: Faldaprevir

Other Names:

BI 201335

Drug: TD-6450

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California Research Center	Coronado	California	United States	92118
2	Bach and Godofsky Infectious Diseases	Bradenton	Florida	United States	34209
3	Gastro One	Germantown	Tennessee	United States	38138
4	Auckland Clinical Studies	Auckland		New Zealand
5	Dunedin Hospital	Dunedin		New Zealand
6	Waikato Hospital	Waikato		New Zealand