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

Octapharma

Status and phase: Terminated; Phase 3

Conditions: Thrombotic Thrombocytopenic Purpura (TTP)

Treatments: Biological: Uniplas; Biological: Cryosupernatant plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411801

UNI-108

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Uniplas

Experimental group

Description:

Participants will receive Uniplas intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.

Treatment:

Biological: Uniplas

Cryosupernatant plasma

Active Comparator group

Description:

Participants will receive cryosupernatant plasma intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.

Treatment:

Biological: Cryosupernatant plasma