A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

Theravance Biopharma1 site in 1 country47 target enrollmentMay 2014

ConditionsHepatitis C HCV

InterventionsTD-6450 Placebo

DrugsTD-6450 Placebo

Overview

Phase: Phase 1
Intervention: TD-6450
Conditions: Hepatitis C
Sponsor: Theravance Biopharma
Enrollment: 47
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

November 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Theravance Biopharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is HCV antibody positive
•Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals.
•Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening that clearly excludes cirrhosis. If not available prior to Screening, the absence of cirrhosis must be confirmed prior to subject enrollment using either Fibroscan or Fibrosure®.
•Subject is negative for hepatitis A (HAV), hepatitis B (HBV), and human immunodeficiency virus (HIV).

Exclusion Criteria

•Subject has prior histological evidence of cirrhosis or current clinical evidence of cirrhosis in the opinion of the investigator.
•Subject has a history or evidence of non-hepatitis C chronic liver disease.
•Subject has an estimated creatinine clearance of \<80 ml/min if 18-60 years of age, inclusive; or \<70 ml/min if \>60 years of age, calculated using the Cockcroft-Gault equation.