Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis

NCT07867821 | Recruiting

• 1 other identifier: 5469
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hemophilia A and B

Keywords

Hemophilia

Outcome Measures

Primary Outcomes (1)

• gene expression

  Study of gene expression in samples of synovial membrane or blood

  At the time of surgery

Study Arms (1)

Sinoviectomy

EXPERIMENTAL

Sinoviectomy

Procedure: Surgery

Interventions

Surgery PROCEDURE

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.

Sinoviectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current presence of an inhibitor (anti-FVIII or anti-FIX);
• Inability to give informed consent to participate in the study.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Roberta Gualtierotti, Principal Investigator

CONTACT

+390255034072; roberta.gualtierotti@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 24, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

IT (1)