At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
SHP655 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics, Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment
In Brief
A Phase 2 clinical trial evaluating Placebo, SHP655, and 1 other intervention for Acquired Thrombotic Thrombocytopenic Purpura (aTTP). Completed, enrolled 28 participants across 24 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP) participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Italy, Spain, United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartOct 2019
Primary CompletionAug 2021
TodayJul 2026
First PostedApr 19, 2019
Enrollment StartOct 9, 2019
Primary CompletionAug 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.2 years ago
Interventions
Placeboother
Participants will receive injection of placebo matched to SHP655.
SHP655drug
Participants will receive injection of SHP655.
Standard of Careother
Participants will receive PEX as Standard of Care (SOC).