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

NCT ID: NCT00411801

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-02-29

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Uniplas

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.

Group Type: EXPERIMENTAL

Uniplas

Intervention Type: BIOLOGICAL

Uniplas will be provided frozen in sterile plastic bags.

Cryosupernatant plasma

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.

Group Type: ACTIVE_COMPARATOR

Cryosupernatant plasma

Intervention Type: BIOLOGICAL

Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Interventions

Uniplas

Uniplas will be provided frozen in sterile plastic bags.

Intervention Type: BIOLOGICAL

Cryosupernatant plasma

Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Intervention Type: BIOLOGICAL

Other Intervention Names

Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Frenzel, M.D.

Role: STUDY_DIRECTOR

Octapharma

Locations

Contact Octapharma for Facility Details

Centreville, Virginia, United States

Countries

United States

Other Identifiers

UNI-108

Identifier Type: -

Identifier Source: org_study_id