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

Completed

• Conditions: Hemophilia

• Registration Number: NCT03596814
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed 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 (€).

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Study Start: 2019-11-13
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2072

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparison of the consumptions of CF before and after the laucnh of EHL CF is an assessment of the the impact of EHL CF on the treatment of haemophiliacs patients	24 months (1st July 2015- 30th June 2016 & 1st July 2017-30th June 2018 (before and after the launch of extended half-life CF in France))	Deletion of the measure of % of switch

Trial Locations

Locations (7)

Rennes University Hospital; 🇫🇷 Rennes, France

Tours University Hospital; 🇫🇷 Tours, France

Le Mans University Hospital; 🇫🇷 Le Mans, France

Nantes University Hospital; 🇫🇷 Nantes, France

Angers University Hospital; 🇫🇷 Angers, France

Brest University Hospital; 🇫🇷 Brest, France

Caen university Hospital; 🇫🇷 Caen, France