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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2072 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-13

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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 (€).

Conditions

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Hemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No Interventional study

Retrospective data

Intervention Type OTHER

Eligibility Criteria

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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.