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Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

NCT00486278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-03-07

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B

Interventions

DRUG

eptacog alfa (activated)

90 mcg/kg, injected i.v.

DRUG

vatreptacog alfa (activated)

5 mcg/kg, injected i.v.

DRUG

vatreptacog alfa (activated)

10 mcg/kg, injected i.v.

DRUG

vatreptacog alfa (activated)

20 mcg/kg, injected i.v.

DRUG

vatreptacog alfa (activated)

40 mcg/kg, injected i.v.

DRUG

vatreptacog alfa (activated)

80 mcg/kg, injected i.v.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Croatia
  • France
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Poland
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00486278 on ClinicalTrials.gov