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
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
sequential cohorts receiving doses orally twice daily for 5 days
orally twice daily for 5 days
Unnamed facility
Ho Chi Minh City, Vietnam
Safety and tolerability: Adverse events, laboratory parameters, vital signs
Time frame: days 1-7 and on follow-up days 14, 28 and 84
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
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