Acquired Bleeding Disorder, Dengue Haemorrhagic Fever
Conditions
Brief summary
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).
Interventions
DRUGactivated recombinant human factor VII
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
DRUGplacebo
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients with the clinical diagnosis of Dengue Haemorrhagic Fever (DHF) * Patients with a clinical diagnosis of DHF Grades II and III8, requiring standard replacement therapy
Exclusion criteria
* Patients with a clinical diagnosis of DHF Grade IV * Known or suspected allergy to trial product or related products * Known hypersensitivity to mouse, hamster or bovine protein * Prior treatment with activated recombinant human factor VII
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration | — |
Secondary
| Measure | 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 | — |
| Coagulation related variables | — |
| Adverse events | — |
Countries
Malaysia, Philippines, Thailand
Outcome results
None listed