Health Condition 1: null- Severe Haemophilia A Children
Conditions
Interventions
Intervention1: EMOCLOT: EMOCLOT 500 IU/10 mL Powder and solvent for solution for infusion.
EMOCLOT 1000 IU/10 mL Powder and solvent for solution for infusion
Posology: a standard dose of 25-50 IU/
Sponsors
Sintesi Research Srl
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1.Previously treated patients aged 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 4.If subjects are HIV-1 seropositive they should have a CD4+ lymphocyte count >= 200/µl 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/µl) 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.)Efficacy: Evaluation of the haemostatic efficacy of Kedrion human plasma-derived factor VIII EMOCLOT in the management of acute bleeding events. 2.)Safety: Assessment of the risk of inhibitor (neutralizing anti-factor VIII antibodies) development in conjunction with infusion of the IMP throughout the study period.Timepoint: At 10-15 EDs or Every 3 Months At 25±2 EDs and at 50 EDs For PK study participating subject safety and efficacy assessment also will be done at pre infusion and 30 Minutes, 1-3 hours, 4-6 hours, 10-14 hours, 20-26 hours & 32-48 hours post infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed