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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balapiravir [RO4588161] | Drug | sequential cohorts receiving doses orally twice daily for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Adverse events, laboratory parameters, vital signs | days 1-7 and on follow-up days 14, 28 and 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | days 1-7 and 14 | |
| Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites | multiple sampling days 1 and 5 | |
| Body temperature |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ho Chi Minh City | District 5 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22807519 | Derived | 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. |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| C530825 | balapiravir |
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| placebo |
| Drug |
orally twice daily for 5 days |
|
| days 1-7 and on follow-up days 14, 28 and 84 |
| Immunological parameters: plasma samples (cytokines) | days 1-7 and 14 |
| 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 |
| Quality of life | assessments days 1, 3, 5, 7, 14, 28 and 84 |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |