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)
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJanuary 19, 2021
January 1, 2021
5 months
April 15, 2014
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Number, type, severity, and association of treatment emergent adverse events.
28 Days
Secondary Outcomes (7)
Cmax
28 Days
Tmax
28 Days
AUC0-t
28 Days
AUC0-∞
28 Days
AUC0-24
28 Days
- +2 more secondary outcomes
Study Arms (2)
TD-6450
EXPERIMENTALTD-6450 capsules
Placebo
PLACEBO COMPARATORPlacebo capsules
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Liver Institute
San Antonio, Texas, 78215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 17, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
January 19, 2021
Record last verified: 2021-01