Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2002-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Dengue Haemorrhagic Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rFVIIa

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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