Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura
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|ClinicalTrials.gov Identifier: NCT01754545|
Recruitment Status : Withdrawn (altered situation in study population; not enough patients meeting enrollment criteria)
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Purpura, Thrombotic Thrombocytopenic||Drug: Octaplas infusion and placebo (group 1) Drug: Octaplas infusion and placebo (group 2)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Octaplas infusion and placebo (group 1)
Active treatment with randomly assigned 400 ml octaplas intravenously 2-3 times a week and 400 ml placebo (for octaplas)intravenously 2-3 times a week over two weeks.
Drug: Octaplas infusion and placebo (group 1)
Intervention period is Monday-Friday in two following weeks. Active treatment with Octaplas is given 2-3 times each week and placebo is given the other 2-3 days of intervention each week. Route of administration is intravenously.
Experimental: Octaplas infusion and placebo (group 2)
Active treatment with randomly assigned 400 ml octaplas intravenously once and 400 ml placebo (for octaplas)intravenously twice in two separate intervention weeks
Drug: Octaplas infusion and placebo (group 2)
Intervention period is Monday-Wednesday in two separate weeks (minimum of three weeks between intervention weeks). Active treatment with Octaplas is given once and placebo is given twice each week. Route of administration is intravenously.
- A composite score of clinical and biochemical signs of disease activity [ Time Frame: 4 hours and 24 hours after intervention ]
Biochemical signs of disease activity are scored by measurements of lactate dehydrogenase, hemoglobin, platelet counts and ADAMTS13 activity.
Clinical signs of disease activity are measured by an evaluator's score and subjects symptom screening
- ADAMTS13 activity half-life [ Time Frame: 4 hours and 24 hours after intervention ]Calculation of half-life of ADAMTS13 activity based on serial measurements of ADAMTS13 activity before and after plasma infusions
- ADAMTS13 allo-antibodies [ Time Frame: At baseline ]Presence of allo-antibodies towards ADAMTS13
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754545
|Principal Investigator:||Anne S von Krogh, MD||St. Olavs Hospital|