NCT02060305

Intra-articular Bevacizumab for Recurrent Hemarthroses at Target Joints With Chronic Hemophilic Synovitis

Terminated Phase 1 Last updated 6 July 2021

What this trial tests

Phase 1 trial testing Bevacizumab intra-articular injection in Hemophilia in 5 participants. Terminated before completion.

Timeline

1 February 2014

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 February 2014
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Bevacizumab intra-articular injection — full drug profile →

Conditions studied

• Hemophilia — all drugs for Hemophilia →
• Synovitis — all drugs for Synovitis →

Sponsor

National Taiwan University Hospital

Who can join

18 and older, any sex, with Hemophilia or Synovitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective The efficacy of intra-articular bevacizumab injection for secondary prevention of recurrent hemarthroses for hemophilia patients who has had target joints with chronic synovitis. The safety profiles of intra-articular bevacizumab injection for hemophilia patients.

Study Population Adult hemophilia patients who have had one or more target joints with chronic synovitis and recurrent hemarthroses.

Investigational therapy: Intra-articular injection of Bevacizumab (20 or 40 mg/ 0.8 or 1.6 ml/ dose) every month (28 days) for up to 4 months, depending on the improvement of target joint bleeding.

Study Design The estimated study period is between Jan 2014 and Dec 2015. Totally 10 joints will be enrolled for this pilot study. Before enrollment, the joint(s) will be evaluated for their severity both clinically (by 10-point Pain Score, range of motion for the target joint, and World Federation of Hemophilia Score) and by MRI (using the compatible MRI scales developed by International Prophylaxis Study Group \[IPSG\]). Intra-articular injection of bevacizumab will be administered, after prophylactic factor supplementation, every month for up to four injections. In the first four patients, 20mg of bevacizumab will be administered. If there are no Gr 3 or Gr4 dose-limiting toxicities, bevacizumab dose will be escalated to 40mg in the other 6 patients. Before every procedure, the plasma and the synovial fluid samples will be collected for VEGF quantification for the correlative biomarker study. After completing the protocol treatment, the efficacy parameters as well as the safety profiles will be evaluated.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting VEGF and Its Receptors for the Treatment of Osteoarthritis and Associated Pain.
   Hamilton JL, Nagao M, Levine BR, Chen D, et al · · 2016 · cited 203× · PMID 27163679 · DOI 10.1002/jbmr.2828
2. Asymptomatic Joint Bleeding and Joint Health in Hemophilia: A Review of Variables, Methods, and Biomarkers.
   Gooding R, Thachil J, Alamelu J, Motwani J, et al · · 2021 · cited 27× · PMID 33833602 · DOI 10.2147/jbm.s304597
3. Angiogenesis in rheumatoid Arthritis: Pathological characterization, pathogenic mechanisms, and nano-targeted therapeutic strategies.
   Zhao F, Hu Z, Li G, Liu M, et al · · 2025 · cited 5× · PMID 40453697 · DOI 10.1016/j.bioactmat.2025.04.026