Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01601613
NCT01601613CompletedPhase 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 enrollmentStarted: July 2001Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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).

Study Design

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

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

Intervention: activated recombinant human factor VII (Drug)

placebo

Placebo Comparator

Intervention: placebo (Drug)

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT01572740Novo Nordisk A/S257
Completed
Phase 4
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2
NCT01892020Novo Nordisk A/S161
Completed
Phase 3
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone DeficiencyGrowth Hormone DisorderAdult Growth Hormone Deficiency
NCT03075644Novo Nordisk A/S62
Completed
Phase 2
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell TransplantationAcquired Bleeding DisorderBleeding During/Following Surgery
NCT01562158Novo Nordisk A/S100
Completed
Phase 3
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan SyndromeGenetic DisorderNoonan Syndrome
NCT01927861Novo Nordisk A/S51