Publication date context February 19, 2026 marks a regulatory milestone as TRANSHEMO 2 expands the evidence base on transition to adulthood for adolescents with severe haemophilia.
In this regulatory update we report a new ancillary study titled TRANSHEMO 2, linked to the TRANSHEMO project, now listed on ClinicalTrials.gov. The entry describes conditions haemophilia, uses patient questionnaires as the data collection method, and lists Assistance Publique Hopitaux De Marseille as sponsor. The study status is not yet recruiting.
What changed for regulators and clinicians?
The ClinicalTrials.gov listing confirms the introduction of an ancillary study, TRANSHEMO 2, expanding the TRANSHEMO project focus to transition to adulthood among adolescents with severe haemophilia.
The listing signals a shift toward systematic data collection on the determinants and consequences of moving into adulthood for affected youths, with questionnaires providing a structured data source for future analyses. Regulators and clinicians can expect this information to support planning for transition care protocols and related services.
Population and data collection
Participants are adolescents with severe haemophilia. Data will be collected through questionnaires to capture determinants and consequences of the transition to adulthood.
Data collection approach
The primary data collection method is questionnaires, as listed in the study design.
What is TRANSHEMO 2 and who runs it?
TRANSHEMO 2 is an ancillary study to the TRANSHEMO project. Its aim is to examine determinants and consequences of the transition to adulthood for adolescents with severe haemophilia.
Sponsor and status
The listed sponsor is Assistance Publique Hopitaux De Marseille. The study status is not yet recruiting, and the entry appears on ClinicalTrials.gov under the identifier NCT07418827.
External link: ClinicalTrials.gov NCT07418827.
What does the study measure?
The protocol indicates questionnaires will be used to collect data relevant to the determinants and consequences of the transition to adulthood for adolescents with severe haemophilia. The exact endpoints are not listed in the source text.
Why this matters for policy and practice?
Findings from TRANSHEMO 2 could inform patient centric care models and regulatory perspectives on patient reported outcomes in the haemophilia population. The MDR framework emphasizes evidence of performance and safety; results from an ancillary study can shape guidance around transition care programs and future device or tool development that supports young patients as they become adults.
FAQs
- 1) What is TRANSHEMO 2?
It is an ancillary study to the TRANSHEMO project that seeks to examine determinants and consequences of adulthood transition for adolescents with severe haemophilia.
- 2) Who funds or sponsors this study?
Assistance Publique Hopitaux De Marseille is listed as sponsor.
- 3) What is the recruitment status?
The entry states not yet recruiting as of the publication date.
- 4) Where can I find more information?
The study is listed on ClinicalTrials.gov with identifier NCT07418827.
Conclusion
TRANSHEMO 2 adds to the regulatory evidence base for haemophilia care as adolescents move toward adulthood. Stakeholders should monitor the listing and any results to inform future guidelines, patient support activities, and regulatory considerations around patient reported data collection.
This information is intended for professionals and is not legal advice. It reflects the source text and publicly available clinical trial data as of the publication date and should not be construed as regulatory guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07418827?term=medical+device