Actively Recruiting

Age: 7Years +
MALE
ID02453542

Global Haemostatic Methods to Measure the Treatment Effect Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors

Led by Karolinska Institutet · Updated on 2025-09-02

20

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to improve treatment monitoring for patients with haemophilia A and B who develop inhibitors to coagulation factors, as well as patients with acquired haemophilia with similar inhibitor issues. The study focuses on evaluating global haemostatic methods to better assess treatment effects, aiming to enhance patient safety and treatment effectiveness. The study is observational and conducted by Karolinska Institutet with patients followed over two years. The study involves collecting blood samples at baseline and before and after administration of bypassing agents used to treat bleeding symptoms or as prophylaxis. Treatments are determined by the patients' physicians and include bypassing agents such as factor eight inhibitor bypassing agent (FEIBA®) or recombinant activated factor VII (rFVIIa). The study evaluates coagulation markers using methods like thrombin generation (Calibrated Automated Thrombogram) and overall haemostatic potential. Participants will have blood samples taken at specific time points during the two-year follow-up to measure changes in coagulation markers in relation to clinical symptoms and inhibitor levels. The research team will analyze these markers alongside patients' clinical outcomes to assess treatment effects. This monitoring aims to provide more accurate information about treatment safety and effectiveness in patients with haemophilia and inhibitors.

CONDITIONS

Brief Title

Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors

Who Can Participate

Age: 7Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent
  • Meets the study population description
  • Male participants aged 7 years or older
Not Eligible

You will not qualify if you...

  • No informed consent
  • Age younger than 7 years
  • Female participants

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.

Long-term Monitoring

Duration - Up to 2 years

Participants are followed up to observe changes in coagulation markers after administration of bypassing agents.

Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Solna, Stockholm County, Sweden, 17176

Actively Recruiting

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Research Team

R

Roza Chaireti, MD, PhD

J

Jovan Antovic, MD, Assoc Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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