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This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIIa | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration | ||
| Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Kuala Lumpur | Malaysia | ||||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16269927 | Result | Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM; Dengue Study Group. Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis. 2005 Nov;16(8):549-55. doi: 10.1097/01.mbc.0000186837.78432.2f. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion. |
|
| Coagulation related variables |
| Adverse events |
| City of Muntinlupa |
| Philippines |
| Novo Nordisk Investigational Site | Manila | Philippines |
| Novo Nordisk Investigational Site | Quezon City | Philippines |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Chiang Mai | 50200 | Thailand |
| Novo Nordisk Investigational Site | Khon Kaen | 40000 | Thailand |
| Novo Nordisk Investigational Site | Pisanulok | 65000 | Thailand |
| Novo Nordisk Investigational Site | Ubonratchathani | 34000 | Thailand |
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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