Brief Title
MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II
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
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 Type
Observational
Primary Outcome
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
Condition
Hemophilia
Intervention
No Interventional study
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
2072
Start Date
November 13, 2019
Completion Date
December 31, 2019
Primary Completion Date
December 31, 2019
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Marc TROSSAERT, Dr, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03596814
Organization ID
RC17_0288
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
Marc TROSSAERT, Dr, Principal Investigator, Nantes University Hospital
Verification Date
May 2020