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CompletedNCT02246868Updated Feb 15, 2018

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

A Phase 3 interventional study of Optivate® (Human Coagulation Factor VIII) in Haemophilia A, sponsored by Bio Products Laboratory. Completed at 11 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-02-15.

Sponsored by Bio Products Laboratory · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Ages
12 Years and older
Sex
All
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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®.

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Conditions studied

  • Haemophilia A

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03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

Browse Hemophilia A studies →

Lead sponsor

Bio Products Laboratory is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Phase 3
Primary purpose
Treatment

Study arms

  • Experimental
    Optivate®

    Optivate® (Human Coagulation Factor VIII)

    Biological: Optivate® (Human Coagulation Factor VIII)

Interventions

  • BiologicalOptivate® (Human Coagulation Factor VIII)
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What researchers measure

Primary outcomes

  1. Incremental Recovery

    Time frame: Comparison of Baseline with 3 months post-baseline

07

Study locations

11 sites
  • Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
    Bialystok, Poland
  • Klinika Haematologii, Akademia Medyczna w Gdansku, u.
    Gdansk, Poland
  • Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
    Lodz, Poland
  • Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
    Lublin, Poland
  • Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
    Poznan, Poland
  • Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.
    Wroclaw, Poland
  • Haemophilia Centre, Addenbrooke's Hospital, Hills Road
    Cambridge, CB2 2QQ, United Kingdom
  • Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary
    Manchester, M13 9WL, United Kingdom
  • Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard
    Nottingham, NG7 2UH, United Kingdom
  • Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
    Sheffield, S10 2JF, United Kingdom
  • Haemophilia Centre, Southampton General Hospital, Tremona Road
    Southampton, SO16 6YD, United Kingdom
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References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02246868
Lead sponsor
Bio Products Laboratory
Responsible party
Sponsor
First posted
Sep 23, 2014
Start date
Sep 2001
Primary completion
Aug 2004
Last update
Feb 15, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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