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BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

NCT00623727 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2013-07-15

Study results available
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Summary

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Conditions

Interventions

BIOLOGICAL

rFVIII-FS/pegylated liposomes (BAY79-4980)

35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm

BIOLOGICAL

rFVIII-FS/WFI (BAY14-2222)

25 IU/kg body weight intravenous 3x/week for 52 weeks

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-04-30
Completion
2010-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Croatia
  • Denmark
  • Estonia
  • France
  • Germany
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Romania
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00623727 on ClinicalTrials.gov