NCT01601613|CompletedPhase 2

Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

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/S ClinicalTrials.gov

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1 other identifier

F7-3015

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredMay 2012

StartedJul 2001

CompletionNov 2002

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jul 2001

Shorter than P25 for phase_2

Geographic Reach

3 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

July 1, 2001

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed

9.5 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed

Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

May 14, 2012

Last Update Submit

January 10, 2017

Conditions

Acquired Bleeding Disorder Dengue Haemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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

Study Arms (2)

rFVIIa

EXPERIMENTAL

Drug: activated recombinant human factor VII

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

rFVIIa

placeboDRUG

100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

placebo

Eligibility Criteria

AgeUp to 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.