Trials / Completed
CompletedNCT03596814
MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,072 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 (€).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Interventional study | Retrospective data |
Timeline
- Start date
- 2019-11-13
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-07-24
- Last updated
- 2020-05-18
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03596814. Inclusion in this directory is not an endorsement.