Trial record 8 of 212 for:    "thrombotic thrombocytopenic purpura" OR "Purpura, Thrombocytopenic"

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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00411801
First received: December 13, 2006
Last updated: October 24, 2015
Last verified: October 2015
  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)
Biological: Uniplas
Biological: Cryosupernatant plasma
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:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Change from baseline in (log) platelet count 1 month after treatment initiation [ Time Frame: Baseline to Month 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Baseline to Month 1 ] [ Designated as safety issue: No ]
    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 Frame: Baseline to Month 1 ] [ Designated as safety issue: No ]
  • Time to reach maximum platelet count [ Time Frame: Baseline to the end of the study (up to 7 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to the end of the study (up to 7 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uniplas
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.
Biological: Uniplas
Uniplas will be provided frozen in sterile plastic bags.
Other Name: Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma
Active Comparator: Cryosupernatant plasma
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.
Biological: Cryosupernatant plasma
Cryosupernatant plasma will be provided frozen in sterile plastic bags.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Octapharma
ClinicalTrials.gov Identifier: NCT00411801     History of Changes
Other Study ID Numbers: UNI-108 
Study First Received: December 13, 2006
Last Updated: October 24, 2015
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, Thrombocytopenic
Purpura
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombophilia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on February 07, 2016