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

Takeda

Status: Enrolling

Conditions: Thrombotic Thrombocytopenic Purpura (TTP)

Treatments: Drug: Recombinant ADAMTS13

Study type: Observational

Funder types: Industry

Identifiers

NCT06441578

jRCT2031240130 (Registry Identifier)

TAK-755-4005

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

- None

Trial design

40 participants in 1 patient group

Recombinant ADAMTS13

Description:

Participants will receive recombinant ADAMTS13 intravenous injection.

Treatment:

Drug: Recombinant ADAMTS13