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Clinical Trials/NCT01601613
NCT01601613
Completed
Phase 2

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

Novo Nordisk A/S1 site in 1 country28 target enrollmentJuly 2001
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ConditionsAcquired Bleeding DisorderDengue Haemorrhagic Fever
Interventionsactivated recombinant human factor VIIplacebo

Overview

Phase
Phase 2
Intervention
activated recombinant human factor VII
Conditions
Acquired Bleeding Disorder
Sponsor
Novo Nordisk A/S
Enrollment
28
Locations
1
Primary Endpoint
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 2001
End Date
November 2002
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

rFVIIa

Intervention: activated recombinant human factor VII

placebo

Intervention: placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

Study Sites (1)

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