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COMPLETEDPHASE1

TD-6450 MAD Study in HCV Infected Subjects

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)

NCT02116543•Theravance Biopharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

November 1, 2014

Last Updated

January 19, 2021

Enrollment

ACTUAL participants

Conditions

Hepatitis CHCV

Interventions

TD-6450

DRUG

Placebo

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

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HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

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HCV

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TD-6450 MAD Study in HCV Infected Subjects

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

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