Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06441578

A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura

This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.

During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Thrombotic Thrombocytopenic Purpura (TTP) Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombophilia Thrombotic Microangiopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13

Exclusion criteria

  • None

Treatment and study plan

Recombinant ADAMTS13

Drug

Recombinant ADAMTS13, Intravenous injection

Other names: ADZYNMA Intravenous 1500, TAK-755

Primary outcomes

  1. Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)

    Time frame: Up to 18 Months

Secondary outcomes

  1. Percent Change in Observed Platelet Count from Baseline at the End of Treatment

    Time frame: Up to 18 Months

    Percent change in platelet count from baseline at the end of treatment will be reported.

  2. Percent Change in Observed ADAMTS13 Activity from Baseline at the End of Treatment

    Time frame: Up to 18 Months

    Percent change in ADAMTS13 activity from baseline at the end of treatment will be reported.

  3. Percent Change in Observed ADAMTS13 Inhibitor from Baseline at the End of Treatment

    Time frame: Up to 18 Months

    Percent change in ADAMTS13 inhibitor from baseline at the end of treatment will be reported.

  4. Number of Participants with Thrombotic Thrombocytopenic Purpura (TTP) Events on Periodic Replacement Therapy

    Time frame: Up to 18 Months

    Number of participants with TTP events on periodic replacement therapy will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation)

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Jun 4, 2024
Registry last updated
Oct 7, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.