Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01601613
First received: May 14, 2012
Last updated: May 22, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration [ Designated as safety issue: No ]
  • Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration [ Designated as safety issue: No ]
  • Coagulation related variables [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601613

Locations
Philippines
Manila, Philippines
Thailand
Ubonratchathani, Thailand, 34000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Senior Vice President for Haemophilia R&D Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01601613     History of Changes
Other Study ID Numbers: F7-3015
Study First Received: May 14, 2012
Last Updated: May 22, 2012
Health Authority: Thailand: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Malaysia: Ministry of Health

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014