TD-6450 MAD Study in HCV Infected Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/7/2015 |
| Start Date: | May 2014 |
| End Date: | October 2014 |
| Contact: | Roger Kohler |
| Email: | Rkohler@theravance.com |
| Phone: | 650-808-6400 |
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)
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.
pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1,
GT-2 or GT-3 chronic HCV.
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.
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