TD-6450 MAD Study in HCV Infected Subjects

Hepatitis C Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116543
• Other study ID #: 0110
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HCV
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• TD-6450

• Placebo

Locations

Country	Name	City	State
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number, type, severity, and association of treatment emergent adverse events.	28 Days
Secondary	Cmax	Cmax	28 Days
Secondary	Tmax	Tmax	28 Days
Secondary	AUC0-t		28 Days
Secondary	AUC0-8	AUC0-8	28 Days
Secondary	AUC0-24		28 Days
Secondary	Antiviral Activity	Change from baseline in HCV RNA	28 Days
Secondary	t1/2	t1/2	28 Days