ClinicalTrials.Veeva

Menu

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

O

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems