A Study of Balapiravir in Patients With Dengue Virus Infection

Phase 1

Completed

• Conditions: Dengue
• Interventions: Drug: balapiravir [RO4588161]; Drug: placebo

• Registration Number: NCT01096576
• Lead Sponsor: Hoffmann-La Roche

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Study Start: 2010-07
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	balapiravir [RO4588161]	-
B	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, laboratory parameters, vital signs	days 1-7 and on follow-up days 14, 28 and 84

Secondary Outcome Measures

Name	Time	Method
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