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Prophylaxis Versus On-demand Therapy Through Economic Report

NCT01159587 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2011-04-13

No results posted yet for this study

Summary

The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII \< 1%).

The observational period will cover at least 5 years per patient.

The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.

Conditions

Interventions

DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly

DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

On-demand treatment with product given only for bleeding episodes

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Italy

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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 NCT01159587 on ClinicalTrials.gov