Hemophilia A

Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

NCT01445197 | PHASE 3 | INTERVENTIONAL

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.

7 Sites

1 Participants

Recruiting

28 Days to 11 Years

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Study Site

Vienna,Austria

Study Site

Frankfurt,Germany

Study Site

Hamburg,Germany

Study Site

Athens,Greece

Study Site

Thessaloniki,Greece

Study Site

Milano,Italy

Study Site

Barnaul,Russian Federation

Study Eligibility Criteria

Inclusion Criteria

* Male subjects diagnosed with haemophilia A (≤ 2% FVIII level in the absence of factor replacement, according to their medical history).
* Age 28 days to \<12 years.
* Subject is eligible for immune tolerance induction (ITI) therapy

Exclusion Criteria

* The subject has received ITI previously.
* Subjects with a historical peak inhibitor titre of ≥ 200 BU/mL.
* Concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein A column or plasmapheresis and interferons.
* High risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator.
* Subjects who are human immunodeficiency virus (HIV)-1 or HIV-2 positive (as reported in the medical records or determined at screening).

Additional Studies

Additional studies can be found at ClinicalTrials.gov