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Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

NCT01601613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-01-11

No results posted yet for this study

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).

Conditions

  • Acquired Bleeding Disorder
  • Dengue Haemorrhagic Fever

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2002-11-30
Completion
2002-11-30

Countries

  • Malaysia
  • Philippines
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01601613 on ClinicalTrials.gov