NCT07867834

Brief Summary

In patients with haemophilia, close monitoring of bleeding with optimal adherence to treatment, a personalised treatment programme and the possibility of early diagnosis of haemarthrosis are essential. The TEMPO project will help advance the state of the art in optimal adherence, rigorous monitoring, and accurate and early diagnosis and management of haemarthrosis by collecting and integrating big data in order to personalise the treatment regimen for each patient, as envisaged by the current model of personalised medicine.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Hemophilia

Keywords

Hemophilia

Outcome Measures

Primary Outcomes (1)

  • Veritas Pro score

    Score for adherence to prophylactic treatment

    6 months

Study Arms (2)

TEMPO

EXPERIMENTAL

TEMPO system

Other: TEMPO

CONTROL

NO INTERVENTION

No intervention

Interventions

TEMPOOTHER

Personalized telemedicine

TEMPO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • age (minimum 18 years)
  • hemophilia
  • having a smartphone

You may not qualify if:

  • autoimmune, inflammatory or degenerative diseases that cause arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

TEMPO

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Roberta Gualtierotti, Professor

CONTACT

+39 0255034072roberta.gualtierotti@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

October 19, 2025

Primary Completion

August 31, 2026

Study Completion

September 30, 2026

Last Updated

October 9, 2026

Record last verified: 2025-10

Locations

IT(1)