HemophiliaTEMPONCT07867834
Tight Control of Treatment Adherence and Efficacy by Telemedicine for an Improved Personalized Management of Patients With Hemophilia
A study testing TEMPO in people with Hemophilia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia
- What is being tested?
- TEMPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- age (minimum 18 years)
- hemophilia
- having a smartphone
Who cannot join
- autoimmune, inflammatory or degenerative diseases that cause arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Roberta Gualtierotti, Professor, +39 0255034072, roberta.gualtierotti@unimi.it
About this study
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.
- Conditions
- Hemophilia
- Being tested
- TEMPO
- Keywords
- Hemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEMPOOther
Personalized telemedicine
| Study group | Role | What they receive |
|---|---|---|
| TEMPO | Experimental | TEMPO system Receives: Other: TEMPO |
| CONTROL | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veritas Pro score
Score for adherence to prophylactic treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start19 Oct 2025
- Primary completion31 Aug 2026
- Study completion30 Sep 2026 (estimated)
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 Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867834
- Sponsor's protocol ID
- 6105
- Acronym
- TEMPO
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Control of Treatment Adherence and Efficacy by Telemedicine for an Improved Personalized Management of Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT07867834
- Acronym / sponsor ID
- TEMPO / 6105
- Conditions
- Hemophilia
- Keywords
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 19 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Oct 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEMPO | Experimental | Other: TEMPOTEMPO system |
| CONTROL | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- age (minimum 18 years)
- hemophilia
- having a smartphone
Key exclusion criteria (1 listed)
- autoimmune, inflammatory or degenerative diseases that cause arthritis
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 |
|---|---|---|
| TEMPOPersonalized telemedicine | Other | TEMPO |
Primary outcome
Veritas Pro score
Time frame: 6 months
Score for adherence to prophylactic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEMPO in people with Hemophilia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta Gualtierotti, Professor (+39 0255034072, roberta.gualtierotti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veritas Pro score (time frame: 6 months). 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 9 Oct 2026.