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

Trek Therapeutics, PBC25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Viral Infection Chronic Hepatitis C Hepatitis C (HCV)Hepatitis C Genotype 1

Interventions

FaldaprevirDRUG

TD-6450DRUG

RibavirinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (6)

Southern California Research Center

Coronado, California, United States

Bach and Godofsky Infectious Diseases

Bradenton, Florida, United States

Gastro One

Germantown, Tennessee, United States

Auckland Clinical Studies

Auckland, New Zealand

Outcomes

Primary Outcomes

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

Time frame: Post Treatment Week 12

Secondary Outcomes

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)

Time frame: 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

Time frame: Randomization through End of Study, up to 24 weeks

Data from ClinicalTrials.gov

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