Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
NCT ID: NCT02009761
Last Updated: 2024-03-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2013-12-18
2016-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI 655064 120 mg / 180 mg
The patients were administered 120 mg BI 655064 solution for subcutaneous injection q1w (once a week) subcutaneously for 4 weeks.
Patients who showed an increase in platelet count above or equal to 100 x 10\^9/L continued treatment with 120 mg BI 655064 solution for subcutaneous injection q1w for additional 8 weeks, followed by 12 weeks of follow-up.
Patients whose platelet count stayed below 100 x 10\^9/L continued treatment for 2 weeks with 180 mg BI 655064 solution for subcutaneous injection q1w followed by 120 mg BI 655064 solution for subcutaneous injection q1w for additional 6 weeks, followed by 12 weeks of follow-up.
BI 655064
subcutaneous injection
Interventions
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BI 655064
subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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University of Southern California
Los Angeles, California, United States
New York Hospital, Cornell Medical Center
New York, New York, United States
Countries
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Related Links
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Related Info
Other Identifiers
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1293.7
Identifier Type: -
Identifier Source: org_study_id
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