TD-6450 MAD Study in HCV Infected Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C, HCV

In brief

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.

Key facts

Study ID

NCT02116543

Run by

Theravance Biopharma

People needed

47

Starts

2014-05-01

Expected to finish

2014-11-01

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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