Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

January 10, 2017 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Novo Nordisk Investigational Site
  • Philippines
      • Manila, Philippines
        • Novo Nordisk Investigational Site
      • Muntinlupa City, Philippines
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines
        • Novo Nordisk Investigational Site
  • Thailand
      • 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
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Coagulation related variables

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (ACTUAL)

November 1, 2002

Study Completion (ACTUAL)

November 1, 2002

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7-3015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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