Status:
COMPLETED
Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Thrombocytopenia
Alloimmune Platelet Refractoriness
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Background: \- Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens when people do not have enough normal platelets. Getting a transfusion of another person s plate...
Detailed Description
Platelet transfusion can be a life-saving procedure in preventing or treating serious bleeding in patients who have low and/or dysfunctional platelets. Treatment of blood cancer and other blood diseas...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ages 18-75 years inclusive.
- Ability to comprehend the investigational nature of the study and provide informed consent.
- Thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment related), defined as \<10k/uL without bleeding or \<30K/uL with evidence of life threatening bleeding (intracranial hemorrhage, GI bleeding, pulmonary hemorrhage, uncontrolled epistaxis, hematuria).
- Diagnosed with immune platelet refractoriness, characterized by all of the following:
- Lack of adequate post-transfusion platelet count increment, defined by, CCI \<7500/ul at 10-60 min, and CCI \<5000/ul at 18-24 hrs (in those who had a CCI at 10-60 min greater than or equal to 5000/microl)after at least 2 consecutive transfusions.
- Presence of anti-HLA class A and/or B antibody.
- EXCLUSION CRITERIA:
- Active meningococcal infection.
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make making informed consent impossible.
- Positive pregnancy test for women of childbearing age within 1 week.
- HIV positive test within 3 months
- Paroxysmal Nocturnal Hemoglobinuria (PNH) disease with evidence of intravascular hemolysis.
- Presence ITP/autoimmune thrombocytopenia
- Immune platelet refractoriness responsive to treatment with IVIG
- RE-ENROLLMENT CRITERIA:
- Meet response criteria to the initial treatment or second treatment
- Meets all initial inclusion/exclusion criteria
Exclusion
Key Trial Info
Start Date :
November 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02298933
Start Date
November 21 2014
End Date
August 8 2017
Last Update
January 3 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892