Open Label, Phase III, Multicenter study on Pharmacokinetic, Efficacy and Safety evaluation of Kedrion Factor VIII concentrate (EMOCLOT) in 50 previously treated Haemophilia A Children. - Nil

Sintesi Research Srl0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Previously treated patients aged <12 years.
•2.Prior to study entry, subjects should have a history of at least 50 exposure days for all types of factor VIII containing products, including fresh frozen plasma (FFP). This minimum exposure rate shall be estimated by the Heamophilia treating physician.
•3.Subjects should have severe or moderately severe Heamophilia A as defined by a baseline factor VIII level <1%, documented at pre-enrolment screening on the basis of anamnesis data (i.e., at heamophilia diagnosis).
•4.If subjects are HIV-1 seropositive they should have a CD4+ lymphocyte count >= 200/Âµl documented on 2 consecutive occasions over a 12 months period prior to study entry. The latest CD4+ lymphocyte count qualifying the patient for enrolment (i.e. >= 200/Âµl) should be within 6 months before enrolment in the study.
•5.Legally authorized representatives of the subjects should be informed of the nature of the study, agree to its provision, and sign and date an informed consent and authorization for the participation and data handling approved by the IRB/IEC.
•6.Subjects who will be available for the duration of the study will be included.

•1.Subjects with a detectable inhibitor to factor VIII at the time of enrolment or a history of inhibitor to factor VIII ( 0.6 BU).
•2.Subjects HIV positive who are treated with highly active anti-retroviral therapy (HAART) regimen.
•3.Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial.
•4.Informed Consent and/or the Authorization for Data Handling approved by the EC not signed by parents/legal guardians.
•5.Subjects who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study.

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