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Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Primary Purpose

Acquired Bleeding Disorder, Dengue Haemorrhagic Fever

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
activated recombinant human factor VII
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rFVIIa

placebo

Arm Description

Outcomes

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

Full Information

First Posted
May 14, 2012
Last Updated
January 10, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01601613
Brief Title
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Dengue Haemorrhagic Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rFVIIa
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Primary Outcome Measure Information:
Title
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Secondary Outcome Measure Information:
Title
Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration
Title
Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration
Title
Coagulation related variables
Title
Adverse events

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Manila
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Muntinlupa City
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Quezon City
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Khon Kean
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Pisanulok
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Ubonratchathani
ZIP/Postal Code
34000
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
16269927
Citation
Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM; Dengue Study Group. Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis. 2005 Nov;16(8):549-55. doi: 10.1097/01.mbc.0000186837.78432.2f.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

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