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Completed

NCT Number: NCT01601613

Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

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).

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Key information

Conditions

Acquired Bleeding Disorder Arbovirus Infections Dengue Dengue Haemorrhagic Fever Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Kuala Lumpur, Malaysia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

Placebo

Drug

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

Primary outcomes

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

Secondary outcomes

  1. Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration

  2. Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration

  3. Coagulation related variables

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 18, 2012
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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