A Study of Balapiravir in Patients With Dengue Virus Infection
NCT ID: NCT01096576
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2010-07-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
balapiravir [RO4588161]
sequential cohorts receiving doses orally twice daily for 5 days
B
placebo
orally twice daily for 5 days
Interventions
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balapiravir [RO4588161]
sequential cohorts receiving doses orally twice daily for 5 days
placebo
orally twice daily for 5 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Ho Chi Minh City, , Vietnam
Countries
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References
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Nguyen NM, Tran CN, Phung LK, Duong KT, Huynh Hle A, Farrar J, Nguyen QT, Tran HT, Nguyen CV, Merson L, Hoang LT, Hibberd ML, Aw PP, Wilm A, Nagarajan N, Nguyen DT, Pham MP, Nguyen TT, Javanbakht H, Klumpp K, Hammond J, Petric R, Wolbers M, Nguyen CT, Simmons CP. A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients. J Infect Dis. 2013 May 1;207(9):1442-50. doi: 10.1093/infdis/jis470. Epub 2012 Jul 17.
Other Identifiers
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PP22799
Identifier Type: -
Identifier Source: org_study_id