NCT00411801

Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.

Conditions

• Thrombotic Thrombocytopenic Purpura (TTP)

Interventions

Type	Name	Description
BIOLOGICAL	Uniplas	Uniplas will be provided frozen in sterile plastic bags.
BIOLOGICAL	Cryosupernatant plasma	Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-12-15
• Last updated: 2017-06-21

Locations

1 site across 1 country: United States