A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

NCT02246894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-02-15

No results posted yet for this study

Summary

The main objectives of this study are:

* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.

Conditions

  • Haemophilia A

Interventions

BIOLOGICAL

Optivate® (Human Coagulation Factor VIII)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2005-01-31

Countries

  • Poland

Study Locations

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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 NCT02246894 on ClinicalTrials.gov