Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Phase 2

Completed

• Conditions: Dengue Haemorrhagic Fever; Acquired Bleeding Disorder
• Interventions: Drug: activated recombinant human factor VII; Drug: placebo

• Registration Number: NCT01601613
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rFVIIa	activated recombinant human factor VII	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration

Secondary Outcome Measures

Name	Time	Method
Coagulation related variables
Adverse events
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇭 Ubonratchathani, Thailand