Inhibitor study in patient with hemophilia never treated in the past

Conditions: Infants or children with severe haemophilia A previously untreated with factor concentrates.
MedDRA version: 16.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-002686-19-IT

Lead Sponsor: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 50

Inclusion Criteria

The principal inclusion criteria are:
1) An informed consent, approved by the appropriate Institutional
Review Board(IRB)/Independent Ethics Committee (IEC) has been
administered, signed and dated by the parents or legal rapresentative
of the patients
2) Subject diagnosed with severe haemophilia A defined by a baseline
FVIII:C < 0,01 IU/mL. The FVIII activity has to be confirmed by a central lab. If the confirmatory level is not < 0,01 IU/mL the child
must exit the study
3) Subject weights 3,5 kg or more at the time of his baseline study
evaluation
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The principal exclusion criteria are:
1) Subjects with prior exposure to clotting factor concentrates or blood
products.
2) Subjects with a clinically significant chronic disease other than
hemophilia A.
3) Subjects that are currently partecipating to other investigational
clinical trials