HemophiliaMOTHIF IINCT03596814
MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II
An observational study of Hemophilia, run by Nantes University Hospital at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia
- How many people
- 2,072 participants
- Where
- 7 sitesFrance
- Study dates
- 13 Nov 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- patients under guardianship
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Angers University Hospital
Angers, 49933
Brest University Hospital
Brest, 29609
Caen university Hospital
Caen, 14033
Le Mans University Hospital
Le Mans, 72037
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35033
Tours University Hospital
Tours, 37044
About this study
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
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.
Read the 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
- Hemophilia
- Being tested
- No Interventional study
- Keywords
- Hemophilia A, Hemophilia B, Research database, Clotting Factors, Regimen of Treatment, Impact Budget Analysis
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Interventional studyOther
Retrospective data
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start13 Nov 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc TROSSAERT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596814
- Sponsor's protocol ID
- RC17_0288
- Acronym
- MOTHIF II
- Status last verified
- May 2020
- First submitted
- 22 Mar 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03596814
- Acronym / sponsor ID
- MOTHIF II / RC17_0288
- Conditions
- Hemophilia
- Keywords
- Hemophilia A, Hemophilia B, Research database, Clotting Factors, Regimen of Treatment, Impact Budget Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,072 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventional studyRetrospective data | Other | – |
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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc TROSSAERT, Dr principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.