MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II

Nantes University Hospital (NUH)

Status: Completed

Conditions: Hemophilia

Treatments: Other: No Interventional study

Study type: Observational

Funder types: Other

Identifiers

NCT03596814

RC17_0288

Details and patient eligibility

About

MOTHIF II is a non-interventional, multicenter, retrospective, observational data collection in seven French Haemophilia Treatment Centers of the BERHLINGO network. In the context of the arrival of new extended half-life products, the MOTHIF II study aims to describe the changes in therapeutic management of patients with hemophilia A & B, following the provision of FVIII and FIX extended half-life factors in France; it will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

Full description

Treatment regimens for haemophiliacs patients treated with clotting factors will be analysed globally for the patients of the two periods, by subgroup:

• type of hemophilia: A or B
• severity: severe, moderate, mild
• history of inhibitors

and then for each subgroup:

• by regimen: 1) Prophylaxis 2) On demand 3) ITI
• by type of clotting factors: FVIII or FIX or by-passing agents, plasma-derived or recombinant, standard or extended half-life clotting factors, INN

Will also be included in the analyse:

• demographic data: age (years)
• clinical data: weight (kgs) if available
• treatment data: regimen, consumptions (number of UI of clotting factors consumed on the period) and costs of clotting factors (€).

Enrollment: 2,072 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients hemophiliac A or B, with or without inhibitors, included in the Nhemo (7 centres) and the Behrlingo database, treated with factor 8 or factor 9 products or by-passing agents
• All Hemophilia A or B patients of any severity without inhibitors, included in the NHEMO database and the BEHRLINGO database, without any treatment by clotting factors
• All Hemophilia A or B patients having given consent to be included in the study (2 times 12 months), during their usual follow-up (consultation...). For the other patients, a derogation from the obligation to inform the patients will be made to the CNIL.

Exclusion criteria

• patients under guardianship