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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008378-29-FR

Enrollment

200

Registered

2009-04-03

Start date

2009-05-20

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with haemophilia A MedDRA version: 9.1 Level: LLT Classification code 10018937 Term: Haemophilia A MedDRA version: 9.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) MedDRA version: 9.1 Level: LLT Classification code 10056492 Term: Haemophilia A with anti factor VIII

Interventions

Trade Name: FACTANE 100UI/ml Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: KOGENATE Bayer 250 UI Pharmaceutical Form: Powder and solvent for solution for injection T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patient at any age suffering from severe (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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To document, the success rate of immune tolerance induction (ITI) (time and issues) after collection of patient data. ;Secondary Objective: - to document the success rate of the different types of products selected for ITI, - to document the impact of inhibitor titres at start of ITI and during the course of ITI, including the peak titre of the inhibitor - to correlate the rating of ITI success by the individual in vitro testing and batch selection - to document adverse drug reactions and related events occuring during the ITI-treatment phase - to document the compliance with the ITI-treatment regimen - to document the time necessary to achieve complete or partial success of individualized ITI during the study;Primary end point(s): The primary end point is defined according to the following criteria : COMPLETE SUCCESS - inhibitor titre 2 months (at least 2 consecutive determinations) - Incremental recovery of FVIII in the normal range (>= 80%) for > 2 months (at least 2 consecutive determinations) - half-life of FVIII >= 7 hours PARTIAL SUCCESS - two of the three criteria above met PARTIAL RESPONSE - One of the three criteria above met FAILURE - No substantial change of the inhibitor titre within 12 months of ITI	—

Measure

Time frame

Main Objective: To document, the success rate of immune tolerance induction (ITI) (time and issues) after collection of patient data. ;Secondary Objective: - to document the success rate of the different types of products selected for ITI, - to document the impact of inhibitor titres at start of ITI and during the course of ITI, including the peak titre of the inhibitor - to correlate the rating of ITI success by the individual in vitro testing and batch selection - to document adverse drug reactions and related events occuring during the ITI-treatment phase - to document the compliance with the ITI-treatment regimen - to document the time necessary to achieve complete or partial success of individualized ITI during the study;Primary end point(s): The primary end point is defined according to the following criteria : COMPLETE SUCCESS - inhibitor titre 2 months (at least 2 consecutive determinations) - Incremental recovery of FVIII in the normal range (>= 80%) for > 2 months (at least 2 consecutive determinations) - half-life of FVIII >= 7 hours PARTIAL SUCCESS - two of the three criteria above met PARTIAL RESPONSE - One of the three criteria above met FAILURE - No substantial change of the inhibitor titre within 12 months of ITI

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026