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

Hemophilia Clinical Trial

Official title: Retrospective and Descriptive Analysis of the Regimens of Treatment With FVIII, FIX and By-passing Agents for Hemophiliacs A or B With or Without Inhibitors, From the Existing Registry BERHLINGO, Before and After the Launch of New Entended Half-life Clotting Factors in Seven Haemophilia Treatment Centers in France

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 (€). ;

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

• NCT number: NCT03596814
• Study type: Observational
• Source: Nantes University Hospital
• Status: Completed
• Start date: November 13, 2019
• Completion date: December 31, 2019