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

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Conditions

Haemophilia A

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL

Eligibility

Sex: ALLMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII. Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study. Exclusion Criteria: \-

Locations (5)

Children's Haematology and Oncology Clinic, Ul.

W. Chodzki Str., Lublin Voivodeship, Poland

Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.

Krakow, Poland

Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.

Poznan, Poland

Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.

Outcomes

Primary Outcomes

Consumption of FVIII

Time frame: Day 0 to Week 26

Data from ClinicalTrials.gov

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