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

Tracking Information

First Received Date ^ICMJE

December 13, 2006

Last Updated Date

February 27, 2008

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00411801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Blinded Non-Inferiority Study To Compare Uniplas With Cryosupernatant Plasma In Thrombotic Thrombocytopenic Purpura (TTP)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Thrombotic Thrombocytopenic Purpura (TTP)

Intervention ^ICMJE

Drug: Uniplas

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

112

Estimated Completion Date

May 2008

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00411801

Other Study ID Numbers ^ICMJE

UNI-108

Has Data Monitoring Committee

Yes

Responsible Party

Robin Scully, Director of Clinical Research, Octapharma

Study Sponsor ^ICMJE

Octapharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Wolfgang Frenzel, M.D.

Octapharma

Information Provided By

Octapharma

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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