Adzynma in people with congenital TTP: a look at safety and antibody risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines adults and children with congenital TTP who have been treated with Adzynma. It focuses on the risk of developing neutralizing antibodies to Adzynma within six months after first exposure in the study population. No new intervention is being tested, and the aim is to gather real-world safety data. Participants must have a documented Adzynma treatment and provide informed consent. The study is conducted at several European centers under Takeda sponsorship.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Is diagnosed with cTTP.
2. Had received commercially available Adzynma treatment for cTTP within the eligibility period of which there must be a recorded date and dose of at least one Adzynma administration in their medical chart.
3. Provides a signed informed consent form (informed consent form \[ICF\]; or assent and consent forms, if applicable), in accordance with local ethical and institutional requirements.

Exclusion criteria:

1. Has a history or presence of a functional ADAMTS13 inhibitor (that is, neutralizing antibodies to ADAMTS13/rADAMTS13).
2. Has concurrent use of an investigational drug or is enrolled in another clinical trial at the time of index Adzynma infusion.

Where it's running

• AKH - Medizinische Universitaet Wien
  Vienna, Austria Recruiting
• Universitatsklinikum Bonn
  Bonn, Germany Recruiting
• Universitaetsklinikum Koeln
  Cologne, Germany Recruiting
• Universitaetsklinikum Leipzig
  Leipzig, Germany Recruiting
• Klinikum Rechts der Isar der Technischen Universitaet Muenchen
  München, Germany Recruiting
• LMU Klinikum
  München, Germany Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with Thrombotic Thrombocytopenic Purpura in Turkey

  This study is collecting information from patients with Thrombotic Thrombocytopenic Purpura in Turkey to see how the disease is treated and how it affects their health over time.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.