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

Hoffmann-La Roche0 sites64 target enrollmentJuly 2010

ConditionsDengue

Interventionsbalapiravir [RO4588161]placebo

Drugsbalapiravir [RO4588161]placebo

Overview

Phase: Phase 1
Intervention: balapiravir [RO4588161]
Conditions: Dengue
Sponsor: Hoffmann-La Roche
Enrollment: 64
Primary Endpoint: Safety and tolerability: Adverse events, laboratory parameters, vital signs
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

April 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•male patients, 18-65 years of age
•dengue virus infection (confirmed by NS1 strip test) with symptom onset \</=48 hours before first study drug administration
•patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
•BMI between 18 and 35

Exclusion Criteria

•positive test at screening for HIV using point of care test, or known HIV infection
•history of any disease known to cause significant alteration in immunologic function or autoimmune disease
•patients taking steroid or other immuno-suppressive therapies
•positive test for drugs of abuse or alcohol using point of care test
•clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome

Arms & Interventions

A

Intervention: balapiravir [RO4588161]

B

Intervention: placebo

Outcomes

Primary Outcomes

Safety and tolerability: Adverse events, laboratory parameters, vital signs

Time Frame: days 1-7 and on follow-up days 14, 28 and 84

Secondary Outcomes

Quality of life(assessments days 1, 3, 5, 7, 14, 28 and 84)
Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites(multiple sampling days 1 and 5)
Body temperature(days 1-7 and on follow-up days 14, 28 and 84)
Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)(days 1-7, and on follow-up days 14, 28 and 84)
Viral load(days 1-7 and 14)
Immunological parameters: plasma samples (cytokines)(days 1-7 and 14)