MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FA... | NCT03596814

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

NCT03596814

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

May 18, 2020Actual

Enrollment

2,072Actual

Phase

Not provided

Conditions

Hemophilia

Interventions

No Interventional study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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 Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 22, 2018

First Submission Date that Met QC Criteria

Jul 13, 2018

First Posted Date

Jul 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2020

Last Update Posted Date

May 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (€).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,072Actual

Name	Type	Description	Arm Group Labels	Other Names
No Interventional study	Other	Retrospective data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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))

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc TROSSAERT, Dr	Nantes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital		Angers		49933	France
Brest University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D002836	Hemophilia B

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided