A phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also know as BAX930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw-Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513839-24-00

Acronym

TAK-755-3002

Enrollment

Registered

2024-07-18

Start date

2021-09-07

Completion date

Unknown

Last updated

2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Thrombotic thrombocytopenic purpura (cTTP)

Brief summary

There is no primary efficacy endpoint for this study, as the primary objective of the study is long-term safety.

Detailed description

The key secondary efficacy outcome measure is the incidence of acute TTP events among subjects receiving TAK755 prophylactically. Analyses will be conducted using FAS for the prophylactic cohort. The number and incidence rate of acute TTP events will be summarized by enrollment status (""Naïve"" or having completed the Phase 3 pivotal study [Study 281102]) and overall.

Interventions

DRUGRECOMBINANT ADAMTS13 (rADAMTS13)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
There is no primary efficacy endpoint for this study, as the primary objective of the study is long-term safety.	—

Secondary

Measure	Time frame
The key secondary efficacy outcome measure is the incidence of acute TTP events among subjects receiving TAK755 prophylactically. Analyses will be conducted using FAS for the prophylactic cohort. The number and incidence rate of acute TTP events will be summarized by enrollment status (""Naïve"" or having completed the Phase 3 pivotal study [Study 281102]) and overall.	—

Countries

Austria, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026