An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

NCT02246868 · 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 compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Conditions

  • Haemophilia A

Interventions

BIOLOGICAL

Optivate® (Human Coagulation Factor VIII)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2004-08-31

Countries

  • Poland
  • United Kingdom

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 NCT02246868 on ClinicalTrials.gov