Back to resultsSafety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Primary Purpose
Thrombotic Thrombocytopenic Purpura (TTP)
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Uniplas
Cryosupernatant plasma
Sponsored by
About this trial
This is an interventional treatment trial for Thrombotic Thrombocytopenic Purpura (TTP) focused on measuring bleeding disorder, universal plasma, plasma, plasma exchange
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.
Sites / Locations
- Contact Octapharma for Facility Details
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Uniplas
Cryosupernatant plasma
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of participants who died at 1 and 3 months after treatment initiation
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.
Total volume of plasma exchange fluid administered during treatment cycles up to 1 month
Time to reach maximum platelet count
Platelet count was reported in units, where 1 unit = 10^9/L platelets.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00411801
Brief Title
Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Official Title
A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombotic Thrombocytopenic Purpura (TTP)
Keywords
bleeding disorder, universal plasma, plasma, plasma exchange
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uniplas
Arm Type
Experimental
Arm 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.
Arm Title
Cryosupernatant plasma
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Uniplas
Other Intervention Name(s)
Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma
Intervention Description
Uniplas will be provided frozen in sterile plastic bags.
Intervention Type
Biological
Intervention Name(s)
Cryosupernatant plasma
Intervention Description
Cryosupernatant plasma will be provided frozen in sterile plastic bags.
Primary Outcome Measure Information:
Title
Change from baseline in (log) platelet count 1 month after treatment initiation
Description
Log platelet count was reported in units, where 1 unit = 10^9/L platelets.
Time Frame
Baseline to Month 1
Secondary Outcome Measure Information:
Title
Percentage of participants who died at 1 and 3 months after treatment initiation
Time Frame
Baseline to Month 3
Title
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
Description
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.
Time Frame
Baseline to Month 1
Title
Total volume of plasma exchange fluid administered during treatment cycles up to 1 month
Time Frame
Baseline to Month 1
Title
Time to reach maximum platelet count
Description
Platelet count was reported in units, where 1 unit = 10^9/L platelets.
Time Frame
Baseline to the end of the study (up to 7 months)
Title
Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study
Description
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.
Time Frame
Baseline to the end of the study (up to 7 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Frenzel, M.D.
Organizational Affiliation
Octapharma
Official's Role
Study Director
Facility Information:
Facility Name
Contact Octapharma for Facility Details
City
Centreville
State/Province
Virginia
ZIP/Postal Code
20120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
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