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

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

An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.

NCT02246894•Bio Products Laboratory

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 6 years

Sex

ALL

Healthy Volunteers

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.

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.

Warsaw, Poland

Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.

Wroclaw, Poland

Key Dates

Start Date

November 1, 2003

Primary Completion Date

January 1, 2005

Last Updated

February 15, 2018

Conditions

Haemophilia A

Interventions

Optivate® (Human Coagulation Factor VIII)

BIOLOGICAL

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

NCT06285071

Haemophilia AHaemophilia B

View study

ENROLLING_BY_INVITATION

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Haemophilia A, Haemophilia B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

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