Hemophilia A and BTHEMANCT07867821
Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
A study testing Surgery in people with Hemophilia A and B, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Chronic arthropathy is one of the most common complications of haemophilia, affecting up to 90 per cent of patients aged 4 and over in at least one joint. the study aims to assess gene expression in biological samples collected via synovectomy and joint replacement surgery, as well as in peripheral blood, in patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A and B
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 24 Oct 2021to 1 May 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of severe haemophilia A or B
- The need to perform therapeutic arthrocentesis, surgical synovectomy or orthopaedic joint replacement surgery for haemophilic arthropathy in all potentially affected joints.
- signed informed consent
Who cannot join
- Current presence of an inhibitor (anti-FVIII or anti-FIX);
- Inability to give informed consent to participate in the study.
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, 20122
Chiara Suffritti, 3490061035, chiarasuffritti@gmail.com
About this study
Official title: Individuazione di Nuovi Biomarker Nell'Artropatia Emofilica Attraverso Analisi Del Trascrittoma - Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
Chronic arthropathy is one of the most common complications of haemophilia, affecting up to 90 per cent of patients aged 4 and over in at least one joint.
the study aims to assess gene expression in biological samples collected via synovectomy and joint replacement surgery, as well as in peripheral blood, in patients with severe haemophilia A or B; to compare these data with those from patients with osteoarthritis and rheumatoid arthritis; and to correlate the gene expression data with information relating to the clinical and laboratory phenotype, the history of inhibitors, and ultrasound and histological findings.
Read the detailed description
Chronic arthropathy is one of the most common complications of haemophilia, affecting up to 90 per cent of patients aged 4 years and over in at least one joint. The joints most commonly affected are the elbows, knees and ankles. Despite the significant progress made in recent decades in the management of the condition, arthropathy remains one of the main unresolved problems associated with haemophilia.
It is well established that prophylaxis with factor VIII is effective in reducing the risk of joint bleeds and, particularly when started early, is capable of preserving joint structure and function. However, even a single episode of joint bleeding is sufficient to cause irreversible changes to the synovial membrane and predisposes the patient to subsequent bleeds, leading to the development of histopathological changes such as hypertrophy, villous formation, angiogenesis and inflammatory infiltration, and ultimately the onset of chronic arthropathy.
The study aims to assess gene expression in biological samples obtained via synovectomy and joint replacement surgery, and in peripheral blood, from patients with severe haemophilia A or B; to compare these data with those from patients with osteoarthritis and rheumatoid arthritis; and to correlate the gene expression data with information relating to the clinical -laboratory findings, a history of inhibitors, and ultrasound and histological findings.
Endpoints:
- To establish a correlation between the expression of genes associated with inflammation and angiogenesis, as assessed in biopsy samples or synovial fluid, and the severity of haemophilic arthropathy;
- To establish a correlation between the expression of genes associated with inflammation and angiogenesis, as assessed in peripheral blood, and the severity of haemophilic arthropathy.
- In order to assess gene expression in inflammatory and fibrosis pathways - given that it is not possible to obtain samples from healthy individuals - transcriptomic data will be compared with data obtained from samples of osteoarthritis and rheumatoid arthritis as controls for degenerative and inflammatory diseases, respectively.
- Conditions
- Hemophilia A and B
- Being tested
- Surgery
- 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.
SurgeryProcedure or surgery
Participation in the study will be offered to patients with severe haemophilia A or B or to patients with osteoarthritis or rheumatoid arthritis and who, for clinical reasons, require a synovectomy or joint replacement surgery. Patients who give their consent for the collection of biological material will also have blood samples taken for the collection, storage and use of the samples within the timeframe specified by the study.
| Study group | Role | What they receive |
|---|---|---|
| Sinoviectomy | Experimental | Sinoviectomy Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression
Study of gene expression in samples of synovial membrane or blood
Measured: At the time of surgery
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 start24 Oct 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A and BStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867821
- Sponsor's protocol ID
- 5469
- Acronym
- THEMA
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Individuazione di Nuovi Biomarker Nell'Artropatia Emofilica Attraverso Analisi Del Trascrittoma - Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
- ClinicalTrials.gov ID
- NCT07867821
- Acronym / sponsor ID
- THEMA / 5469
- Conditions
- Hemophilia A and B
- Keywords
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (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.
Chronic arthropathy is one of the most common complications of haemophilia, affecting up to 90 per cent of patients aged 4 and over in at least one joint.
the study aims to assess gene expression in biological samples collected via synovectomy and joint replacement surgery, as well as in peripheral blood, in patients with severe haemophilia A or B; to compare these data with those from patients with osteoarthritis and rheumatoid arthritis; and to correlate the gene expression data with information relating to the clinical and laboratory phenotype, the history of inhibitors, and ultrasound and histological findings.
Detailed description
Chronic arthropathy is one of the most common complications of haemophilia, affecting up to 90 per cent of patients aged 4 years and over in at least one joint. The joints most commonly affected are the elbows, knees and ankles. Despite the significant progress made in recent decades in the management of the condition, arthropathy remains one of the main unresolved problems associated with haemophilia.
It is well established that prophylaxis with factor VIII is effective in reducing the risk of joint bleeds and, particularly when started early, is capable of preserving joint structure and function. However, even a single episode of joint bleeding is sufficient to cause irreversible changes to the synovial membrane and predisposes the patient to subsequent bleeds, leading to the development of histopathological changes such as hypertrophy, villous formation, angiogenesis and inflammatory infiltration, and ultimately the onset of chronic arthropathy.
The study aims to assess gene expression in biological samples obtained via synovectomy and joint replacement surgery, and in peripheral blood, from patients with severe haemophilia A or B; to compare these data with those from patients with osteoarthritis and rheumatoid arthritis; and to correlate the gene expression data with information relating to the clinical -laboratory findings, a history of inhibitors, and ultrasound and histological findings.
Endpoints:
- To establish a correlation between the expression of genes associated with inflammation and angiogenesis, as assessed in biopsy samples or synovial fluid, and the severity of haemophilic arthropathy;
- To establish a correlation between the expression of genes associated with inflammation and angiogenesis, as assessed in peripheral blood, and the severity of haemophilic arthropathy.
- In order to assess gene expression in inflammatory and fibrosis pathways - given that it is not possible to obtain samples from healthy individuals - transcriptomic data will be compared with data obtained from samples of osteoarthritis and rheumatoid arthritis as controls for degenerative and inflammatory diseases, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinoviectomy | Experimental | Procedure: SurgerySinoviectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of severe haemophilia A or B
- The need to perform therapeutic arthrocentesis, surgical synovectomy or orthopaedic joint replacement surgery for haemophilic arthropathy in all potentially affected joints.
- signed informed consent
Key exclusion criteria (2 listed)
- Current presence of an inhibitor (anti-FVIII or anti-FIX);
- Inability to give informed consent to participate in the study.
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 |
|---|---|---|
| SurgeryParticipation in the study will be offered to patients with severe haemophilia A or B or to patients with osteoarthritis or rheumatoid arthritis and who, for clinical reasons, require a synovectomy or joint replacement surgery. Patients who give their consent for the collection of biological material will also have blood samples taken for the collection, storage and use of the samples within the timeframe specified by the study. | Procedure or surgery | Sinoviectomy |
Primary outcome
gene expression
Time frame: At the time of surgery
Study of gene expression in samples of synovial membrane or blood
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.
- Individual participant dataSharing planned: Undecided
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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 Surgery in people with Hemophilia A and B, 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 3 inclusion and 2 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, Principal Investigator (+390255034072, roberta.gualtierotti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression (time frame: At the time of surgery). 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.