Trials / Completed
CompletedNCT01601613
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombinant Factor VIIa (NovoSeven®) and Standard Haemostatic Replacement Therapy in Patients With Dengue Haemorrhagic Fever
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | activated 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. |
| DRUG | placebo | 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion. |
Timeline
- Start date
- 2001-07-01
- Primary completion
- 2002-11-01
- Completion
- 2002-11-01
- First posted
- 2012-05-18
- Last updated
- 2017-01-11
Locations
9 sites across 3 countries: Malaysia, Philippines, Thailand
Source: ClinicalTrials.gov record NCT01601613. Inclusion in this directory is not an endorsement.