MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
NCT ID: NCT01609452
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blisibimod
Blisibimod
Placebo
Placebo
Interventions
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Blisibimod
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
3. Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.
Exclusion Criteria
2. Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
3. Nursing or pregnant.
4. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
5. Any known history of bone marrow stem cell disorder.
6. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
7. Liver disease.
8. Malignancy within the past 5 years.
9. History of active tuberculosis (TB) or history of TB infection.
10. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
11. History of congenital immunodeficiency.
18 Years
75 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Other Identifiers
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AN-ITP3321
Identifier Type: -
Identifier Source: org_study_id
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