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

NCT02716428 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-17

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Faldaprevir

DRUG

TD-6450

DRUG

Ribavirin

Sponsors & Collaborators

  • Trek Therapeutics, PBC

    lead INDUSTRY

Principal Investigators

  • Ed Gane, MD · Auckland Clinical Studies Ltd

  • Tarek Hassanein, MD · Southern California Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716428 on ClinicalTrials.gov