A survey on the success of inhibitor elimination using individualized concentrate selection and controlled immune tolerance induction - OBSITI

Phase 1

• Conditions: patients with haemophilia A; MedDRA version: 9.1Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII); MedDRA version: 9.1Level: LLTClassification code 10056492Term: Haemophilia A with anti factor VIII; MedDRA version: 9.1Level: LLTClassification code 10018937Term: Haemophilia A

• Registration Number: EUCTR2008-008378-29-FR
• Lead Sponsor: CHU de Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-03
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- patient at any age suffering from severe (FVIII activity <= 1%), moderate (FVIII activity 1% - 5%), or mild (FVIII activity > 5%) haemophilia A with relevant inhibitor levels (> 0,6 Bethesda Unit)
OR who failed an earlier ITI attempt
- consent form signed (or parents' consent form signed)
- affiliated of a social regimen (or parents affiliated of a social regimen)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patient with congenital or acquired bleeding defects other than haemophilia A
- patient with concomitant immunological diseases or receiving immunosuppressive treatement
- patient with a history of hypersensitivity to blood products and/or FVIII concentrates

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified