Clinical Trial: A Study of Balapiravir in Patients With Dengue Virus Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
Brief Summary: This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Safety and tolerability: Adverse events, laboratory parameters, vital signs [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Viral load [ Time Frame: days 1-7 and 14 ]
- Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites [ Time Frame: multiple sampling days 1 and 5 ]
- Body temperature [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]
- Immunological parameters: plasma samples (cytokines) [ Time Frame: days 1-7 and 14 ]
- Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count) [ Time Frame: days 1-7, and on follow-up days 14, 28 and 84 ]
- Quality of life [ Time Frame: assessments days 1, 3, 5, 7, 14, 28 and 84 ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: March 17, 2010
Date Started: July 2010
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
