Back to resultsTD-6450 MAD Study in HCV Infected Subjects
Primary Purpose
Hepatitis C, HCV
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-6450
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, HCV
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.
Sites / Locations
- Texas Liver Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TD-6450
Placebo
Arm Description
TD-6450 capsules
Placebo capsules
Outcomes
Primary Outcome Measures
Adverse events
Number, type, severity, and association of treatment emergent adverse events.
Secondary Outcome Measures
Cmax
Cmax
Tmax
Tmax
AUC0-t
AUC0-∞
AUC0-∞
AUC0-24
Antiviral Activity
Change from baseline in HCV RNA
t1/2
t1/2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02116543
Brief Title
TD-6450 MAD Study in HCV Infected Subjects
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HCV
Keywords
Hepatitis C, HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-6450
Arm Type
Experimental
Arm Description
TD-6450 capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
TD-6450
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Adverse events
Description
Number, type, severity, and association of treatment emergent adverse events.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Cmax
Description
Cmax
Time Frame
28 Days
Title
Tmax
Description
Tmax
Time Frame
28 Days
Title
AUC0-t
Time Frame
28 Days
Title
AUC0-∞
Description
AUC0-∞
Time Frame
28 Days
Title
AUC0-24
Time Frame
28 Days
Title
Antiviral Activity
Description
Change from baseline in HCV RNA
Time Frame
28 Days
Title
t1/2
Description
t1/2
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TD-6450 MAD Study in HCV Infected Subjects
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