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

Thrombotic Thrombocytopenic Purpura (TTP) Clinical Trial

Official title:

A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00411801
• Other study ID #: UNI-108
• Status: Terminated
• Phase: Phase 3
• First received: December 13, 2006
• Last updated: June 19, 2017
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2017
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• Thrombotic Thrombocytopenic Purpura (TTP)

Intervention

Biological:
• Uniplas
Uniplas will be provided frozen in sterile plastic bags.
• Cryosupernatant plasma
Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Locations

Country	Name	City	State
United States	Contact Octapharma for Facility Details	Centreville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in (log) platelet count 1 month after treatment initiation	Log platelet count was reported in units, where 1 unit = 10^9/L platelets.	Baseline to Month 1
Secondary	Percentage of participants who died at 1 and 3 months after treatment initiation		Baseline to Month 3
Secondary	Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month	A CR was defined as a platelet count > 150 x 10^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is > 50 x 10^9/L. A NR was defined as a < 2-fold increase in platelet count, or a platelet count < 50 x 10^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.	Baseline to Month 1
Secondary	Total volume of plasma exchange fluid administered during treatment cycles up to 1 month		Baseline to Month 1
Secondary	Time to reach maximum platelet count	Platelet count was reported in units, where 1 unit = 10^9/L platelets.	Baseline to the end of the study (up to 7 months)
Secondary	Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study	The percentage of participants with a CR, PR, NR, or TR, as their best clinical response during the study, is reported. A CR was defined as a platelet count > 150 x 10^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is > 50 x 10^9/L. A NR was defined as a < 2-fold increase in platelet count, or a platelet count < 50 x 10^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.	Baseline to the end of the study (up to 7 months)