Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Acquired Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601613
• Other study ID #: F7-3015
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2012
• Last updated: January 10, 2017
• Start date: July 2001
• Est. completion date: November 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug AdministrationPhilippines: Bureau of Food and DrugsMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Dengue
• Dengue Haemorrhagic Fever
• Fever
• Hemostatic Disorders
• Severe Dengue

Intervention

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.
• placebo
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

Locations

Country	Name	City	State
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Philippines	Novo Nordisk Investigational Site	Manila
Philippines	Novo Nordisk Investigational Site	Muntinlupa City
Philippines	Novo Nordisk Investigational Site	Quezon City
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Chiang Mai
Thailand	Novo Nordisk Investigational Site	Khon Kean
Thailand	Novo Nordisk Investigational Site	Pisanulok
Thailand	Novo Nordisk Investigational Site	Ubonratchathani

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Malaysia,  Philippines,  Thailand, 

References & Publications (1)

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 stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration			No
Secondary	Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration			No
Secondary	Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration			No
Secondary	Coagulation related variables			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk