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Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601613
First Posted: May 18, 2012
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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).

Condition Intervention Phase
Acquired Bleeding Disorder Dengue Haemorrhagic Fever Drug: activated recombinant human factor VII Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration

Secondary Outcome Measures:
  • 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

Enrollment: 28
Study Start Date: July 2001
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIIa 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 Comparator: placebo 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601613


Locations
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia
Philippines
Novo Nordisk Investigational Site
Manila, Philippines
Novo Nordisk Investigational Site
Muntinlupa City, Philippines
Novo Nordisk Investigational Site
Quezon City, Philippines
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Chiang Mai, Thailand, 50200
Novo Nordisk Investigational Site
Khon Kean, Thailand, 40000
Novo Nordisk Investigational Site
Pisanulok, Thailand, 65000
Novo Nordisk Investigational Site
Ubonratchathani, Thailand, 34000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01601613     History of Changes
Other Study ID Numbers: F7-3015
First Submitted: May 14, 2012
First Posted: May 18, 2012
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Dengue
Severe Dengue
Fever
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hemostatics
Coagulants