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

NCT ID: NCT06441578

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2032-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombotic Thrombocytopenic Purpura (TTP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recombinant ADAMTS13

Participants will receive recombinant ADAMTS13 intravenous injection.

Recombinant ADAMTS13

Intervention Type DRUG

Recombinant ADAMTS13, Intravenous injection

Interventions

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Recombinant ADAMTS13

Recombinant ADAMTS13, Intravenous injection

Intervention Type DRUG

Other Intervention Names

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ADZYNMA Intravenous 1500 TAK-755

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda selected site

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Related Links

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https://clinicaltrials.takeda.com/study-detail/c2fc7ca33be64ac7

To obtain more information on the study, click here/on this link

Other Identifiers

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jRCT2031240130

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-755-4005

Identifier Type: -

Identifier Source: org_study_id

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