RECRUITINGINTERVENTIONAL

Intra-Articular Bevacizumab for Preventing Recurrent Hemarthrosis in Hemophilia With Chronic Synovitis

Efficacy of Intra-Articular Bevacizumab in Preventing Recurrent Hemarthrosis in Hemophilia Patients With Chronic Synovitis: A Pre- and Post-Design Study

About This Trial

Hemophilia is an inherited bleeding disorder characterized by deficiency of clotting factors, leading to increased bleeding tendencies. The most common complications are joint bleeds (hemarthroses), which cause chronic changes in joints and ultimately disability. Recurrent hemarthroses often result from chronic synovitis in target joints of patients with hemophilia, a process driven by Vascular Endothelial Growth Factor (VEGF) mediated pathological angiogenesis. Intra-articular administration of Bevacizumab, a VEGF neutralizing monoclonal antibody, may block this process and reduce the frequency of recurrent joint bleeds. This study evaluates the efficacy and safety of intra-articular Bevacizumab for preventing recurrent hemarthrosis in patients with hemophilia and chronic synovitis.

Who May Be Eligible (Plain English)

Who May Qualify: - Confirmed diagnosis of Hemophilia A. - Presence of one or more target joints (knee, elbow, ankle) with chronic synovitis and a history of \>2 hemarthrosis episodes in the past 6 months. - Target joint World Federation of Hemophilia (WFH) joint score of 2-3. - Adequate hematological, renal, and liver function (as specified by protocol lab values). - Ability and willingness to provide willing to sign a consent form and comply with the study protocol. Who Should NOT Join This Trial: - HIV positive diagnosis. - Severely damaged joints or anatomical limitations preventing safe injection. - Contraindications to MRI. - Uncontrolled hypertension. - Recent major surgery/trauma (\<28 days). - Serious non-healing wound, active cardiovascular disease, or other significant comorbidities that could increase risk or interfere with the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Confirmed diagnosis of Hemophilia A. * Presence of one or more target joints (knee, elbow, ankle) with chronic synovitis and a history of \>2 hemarthrosis episodes in the past 6 months. * Target joint World Federation of Hemophilia (WFH) joint score of 2-3. * Adequate hematological, renal, and liver function (as specified by protocol lab values). * Ability and willingness to provide informed consent and comply with the study protocol. Exclusion Criteria: * HIV positive diagnosis. * Severely damaged joints or anatomical limitations preventing safe injection. * Contraindications to MRI. * Uncontrolled hypertension. * Recent major surgery/trauma (\<28 days). * Serious non-healing wound, active cardiovascular disease, or other significant comorbidities that could increase risk or interfere with the study.

Treatments Being Tested

DRUG

Intra-articular Bevacizumab

This clinical trial investigates the intra-articular injection of Bevacizumab, a recombinant humanized monoclonal antibody that inhibits Vascular Endothelial Growth Factor (VEGF). The intervention functions by binding to and neutralizing VEGF-A, thereby blocking the pathogenic angiogenesis and vascular permeability that characterizes chronic hemophilic synovitis. For administration, the first four patients will receive a dose of 20 mg in 0.8 mL per injection, and if this is well-tolerated without major toxicities, the dose for all subsequent patients will be increased to 40 mg in 1.6 mL. Each injection will be administered directly into the target joint (knee, elbow, or ankle) once every 28 days for a total of four doses. Crucially, all injections will be performed only after appropriate prophylactic factor replacement to mitigate any procedure-related bleeding risk.

Locations (2)

Hayatabad Medical Complex

Peshawar, KPK, Pakistan

Institute of Pathology and Diagnostic Medicine (IPDM)

Peshawar, KPK, Pakistan