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

NCT03596814 | Completed

• 1 other identifier: RC17_0288
• Study Type: observational
• Target: 2,072
• Locations: 1 country
• Sites: 7

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.

Conditions

Hemophilia

Keywords

Hemophilia A; Hemophilia B; Research database; Clotting Factors; Regimen of Treatment; Impact Budget Analysis

Outcome Measures

Primary Outcomes (1)

• 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

  Deletion of the measure of % of switch

  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))

Interventions

No Interventional study OTHER

Retrospective data

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Estimation of the population of the study: 2 000 patients will be enrolled by seven centers in France (treated or not). Settings : 7 Hemophilia Traitement Center of Western France : Angers, Brest, Caen, Le Mans, Nantes, Rennes and Tours

You may qualify if:

• 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.

You may not qualify if:

• patients under guardianship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (7)

Angers University Hospital

Angers, 49933, France

Location

Brest University Hospital

Brest, 29609, France

Location

Caen university Hospital

Caen, 14033, France

Location

Le Mans University Hospital

Le Mans, 72037, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Tours University Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Marc TROSSAERT, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: July 24, 2018
• Study Start: November 13, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

FR (7)