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

NCT ID: NCT02716428

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Group Type EXPERIMENTAL

Faldaprevir

Intervention Type DRUG

TD-6450

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Cohort 2

12 weeks of Faldaprevir plus TD-6450

Group Type EXPERIMENTAL

Faldaprevir

Intervention Type DRUG

TD-6450

Intervention Type DRUG

Interventions

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Faldaprevir

Intervention Type DRUG

TD-6450

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Other Intervention Names

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BI 201335 Ribasphere®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trek Therapeutics, PBC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ed Gane, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland Clinical Studies Ltd

Tarek Hassanein, MD

Role: PRINCIPAL_INVESTIGATOR

Southern California Research Center

Locations

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Southern California Research Center

Coronado, California, United States

Site Status

Bach and Godofsky Infectious Diseases

Bradenton, Florida, United States

Site Status

Gastro One

Germantown, Tennessee, United States

Site Status

Auckland Clinical Studies

Auckland, , New Zealand

Site Status

Dunedin Hospital

Dunedin, , New Zealand

Site Status

Waikato Hospital

Waikato, , New Zealand

Site Status

Countries

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United States New Zealand

Other Identifiers

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TRK-450-0203

Identifier Type: -

Identifier Source: org_study_id