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Safety and Efficacy Study To Compare Uniplas With Cryosupernatant Plasma In Thrombotic Thrombocytopenic Purpura (TTP)

This study has been terminated.
Sponsor:
Information provided by:
Octapharma
ClinicalTrials.gov Identifier:
NCT00411801
First received: December 13, 2006
Last updated: February 27, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Thrombotic Thrombocytopenic Purpura (TTP)
 Drug: Uniplas
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Blinded Non-Inferiority Study To Compare Uniplas With Cryosupernatant Plasma In Thrombotic Thrombocytopenic Purpura (TTP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Octapharma:

Estimated Enrollment: 112
Study Start Date: December 2006
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Key Inclusion Criteria:
  • 18 years of age and above
  • Definite diagnosis of acute TTP
  • Thrombocytopenia
  • Diagnostic signs of microangiopathic hemolytic anemia

Exclusion Criteria:

  • Key Exclusion Criteria:
  • Congenital thrombotic microangiopathies
  • Alternative secondary cause for microangiopathy
  • Comorbid illness limiting life expectancy to less than three months independent of TTP
  • Patients known to be HIV positive
  • Patients known to have lupus
  • Refusal to accept blood products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411801

Locations
United States, Virginia
Contact Octapharma for Facility Details
Centreville, Virginia, United States, 20120
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Wolfgang Frenzel, M.D. Octapharma
  More Information

No publications provided

Responsible Party: Robin Scully, Director of Clinical Research, Octapharma
ClinicalTrials.gov Identifier: NCT00411801     History of Changes
Other Study ID Numbers: UNI-108
Study First Received: December 13, 2006
Last Updated: February 27, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Octapharma:
bleeding disorder
universal plasma
plasma
plasma exchange

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Thrombosis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
 Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013