Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Novo Nordisk A/S28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Dengue Haemorrhagic Fever

Interventions

activated recombinant human factor VIIDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Novo Nordisk Investigational Site

Kuala Lumpur, Malaysia

Novo Nordisk Investigational Site

City of Muntinlupa, Philippines

Novo Nordisk Investigational Site

Manila, Philippines

Novo Nordisk Investigational Site

Quezon City, Philippines

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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