NCT03922308

Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Interventions

Type	Name	Description
OTHER	Placebo	Participants will receive injection of placebo matched to SHP655.
DRUG	SHP655	Participants will receive injection of SHP655.
OTHER	Standard of Care	Participants will receive PEX as Standard of Care (SOC).

Timeline

• Start date: 2019-10-09
• Primary completion: 2021-08-05
• Completion: 2021-08-05
• First posted: 2019-04-19
• Last updated: 2022-12-01
• Results posted: 2022-12-01

Locations

24 sites across 7 countries: United States, Canada, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study