Actively Recruiting

Phase Not Applicable
All Genders
ID07187661

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

Led by Khyber Medical University Peshawar · Updated on 2025-09-23

25

Participants Needed

2

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of intra-articular Bevacizumab, a monoclonal antibody that blocks Vascular Endothelial Growth Factor (VEGF), to prevent recurrent joint bleeding in patients with Hemophilia A who have chronic synovitis. Hemophilia is a genetic bleeding disorder that often causes repeated bleeding into joints, leading to chronic inflammation and joint damage. This trial seeks to reduce these bleeding episodes and slow joint deterioration by targeting the underlying VEGF-driven process. Participants will receive monthly injections of Bevacizumab directly into affected joints (knee, elbow, or ankle) following preventive factor replacement therapy to avoid bleeding complications. The first four patients will receive 20 mg doses, and if well tolerated, subsequent participants will receive 40 mg doses. Each patient will receive a total of four injections over four months. This open-label, single-arm study will be conducted over two years and involves 25 participants. Throughout the study, researchers will monitor joint bleeding rates before and after treatment, assess joint health using a clinical scoring tool at multiple intervals up to one year, and evaluate joint inflammation and effusion through MRI scans before treatment and six months after completion. The study aims to provide insights into this targeted therapy's potential to improve long-term joint health in hemophilia patients while tracking safety and treatment effects over time.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of Hemophilia A
  • Presence of one or more target joints (knee, elbow, ankle) with chronic synovitis and a history of more than 2 hemarthrosis episodes in the past 6 months
  • Target joint World Federation of Hemophilia joint score of 2-3
  • Adequate blood, kidney, and liver function as specified by protocol
  • Ability and willingness to provide informed consent and follow the study protocol
Not Eligible

You will not qualify if you...

  • HIV positive diagnosis
  • Severely damaged joints or anatomical issues preventing safe joint injections
  • Contraindications to MRI
  • Uncontrolled high blood pressure
  • Recent major surgery or trauma within 28 days
  • Serious non-healing wounds, active heart disease, or other significant health problems that increase risk or interfere with the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 months

Participants receive intra-articular Bevacizumab injections into the target joint once every 28 days for a total of four doses. Injections are given following prophylactic factor replacement therapy to prevent procedure-related bleeding.

4 monthly visits (in-person) for injections

Follow-up

Duration - Up to 12 months after starting treatment

Participants are monitored for changes in joint health and synovial inflammation through clinical assessments and MRI scans for up to 12 months after treatment initiation.

Visits at 1, 3, 6, and 12 months after treatment initiation for assessments

Trial Site Locations

Total: 2 locations

1

Hayatabad Medical Complex

Peshawar, KPK, Pakistan, 25000

Actively Recruiting

2

Institute of Pathology and Diagnostic Medicine (IPDM)

Peshawar, KPK, Pakistan, 25000

Actively Recruiting

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Research Team

D

Dr Kinza Ayaz, MBBS

P

Prof. Dr. Yasar M Yousafzai, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Prevalence of symptoms in hemophilia carriers in comparison with the general population: a systematic review.

André Bubna Hirayama, Alline Karolyne Cândida da Silva, Jordanna Sousa Rocha...

https://pubmed.ncbi.nlm.nih.gov/31412987

Mortality, life expectancy, and causes of death of persons with hemophilia in the Netherlands 2001-2018.

Shermarke Hassan, Rory C Monahan, Evelien P Mauser-Bunschoten...

https://pubmed.ncbi.nlm.nih.gov/33217158

Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries.

Alfonso Iorio, Jeffrey S Stonebraker, Hervé Chambost...

https://pubmed.ncbi.nlm.nih.gov/31499529