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

Stopped early · Phase 3

Conditions studied: Thrombotic Thrombocytopenic Purpura (TTP)

In brief

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.

Key facts

Study ID

NCT00411801

Run by

Octapharma

People needed

8

Starts

2007-05-01

Expected to finish

2008-02-01

Last updated by the study team

2017-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age and above.
• Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).
• Thrombocytopenia.
• Diagnostic signs of microangiopathic hemolytic anemia.

You may not qualify if…

• Congenital thrombotic microangiopathies.
• Alternative secondary cause for microangiopathy.
• Co-morbid illness limiting life expectancy to less than 3 months independent of TTP.
• Patients known to be HIV positive.
• Patients known to have lupus.
• Refusal to accept blood products.

Where it is running

• Contact Octapharma for Facility Details — Centreville, Virginia, United States

Full record on ClinicalTrials.gov

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