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NCT Number: NCT06204042

Multinational Glanzmann Study

Glanzmann thrombasthenia is a rare autosomal recessive platelet disorder characterized by a lack of functional integrins alfaIIb or beta3 (glycoproteins IIb/IIIa). The prevalence is variously reported to be between 1:200,000 to 1:1,000,000, with substantial geographic variation. The clinical phenotype is dominated by an increased mucocutaneous bleeding tendency. In absence of a primary bleeding prophylaxis, the current treatment of Glanzmann thrombasthenia is mainly focused on prevention or management of bleeding. However, as potential new therapies emerge, clinicians require unbiased, long-term safety and efficacy data for both current treatment and new therapies.

We have designed this study to investigate genetic phenotype (ITGA2B and ITGB3 genes) and the prevalence of antibodies against human leucocyte antigen (HLA) and human platelet antigen (HPA), the latter two being a potential consequence of the current golden standard treatment: platelet transfusion. The results of this study will be merged with a longitudinal registry with retrospective and prospective data collection of clinical phenotype, haemorrhagic burden and bleeding management. Analysis of the data from the Glanzmann-NHS+ study and the registry will help us to get a better understanding of the clinical variation among participants with Glanzmann thrombasthenia. The ultimate goal is to accelerate improvement in the care of patients with Glanzmann thrombasthenia.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥16 years);
  • Biochemically or genetically diagnosed Glanzmann thrombasthenia.
  • Willing and able to give written informed consent.

Exclusion criteria

  • Patients with acquired thrombasthenic states caused by auto-immune disorders or drugs.

Treatment and study plan

Primary outcomes

  1. Genetic analysis for Glanzmann thrombasthenia

    Time frame: Single measurement at Baseline

    Description of mutation analysis in the ITGA2B and ITGB3 genes.

Secondary outcomes

  1. Incidence of anti-Human Leucocyte Antigen (HLA) antibodies

    Time frame: Single measurement at Baseline

    Cross-sectional evaluation of existing antibodies against Human Leucocyte Antigen (HLA) type I.

  2. Incidence of anti-Human Platelet Antigen (HPA) antibodies

    Time frame: Single measurement at Baseline

    Cross-sectional evaluation of existing antibodies against Human Platelet Antigen (HPA)

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Glanzmann Thrombasthenia Natural History Study+

Acronym: Glanzmann-NHS

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jan 12, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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