Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
NCT ID: NCT01530256
Last Updated: 2021-02-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2012-03-31
2013-03-31
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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ALD518
ALD518
160 mg IV q 4 weeks for 4 doses
ALD518
320 mg IV q 4 weeks for 4 doses
ALD518
640 mg IV q 4 weeks for 2 doses
Interventions
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ALD518
160 mg IV q 4 weeks for 4 doses
ALD518
320 mg IV q 4 weeks for 4 doses
ALD518
640 mg IV q 4 weeks for 2 doses
Eligibility Criteria
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Inclusion Criteria
* Prior corticosteroid therapy at \> 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
* Karnofsky Performance Satus Scale ≥ 50%
* Adequate laboratory testing at screening
Exclusion Criteria
* Subjects with Stage 3 or 4 liver GVHD
* Prior EBV associated malignancy
* Prior or current Hepatitis B or C
* Prior or active tuberculosis
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Javier San Martin, MD FRCP
Role: STUDY_DIRECTOR
Alder Biopharmaceuticals, Inc.
Locations
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City of Hope
Duarte, California, United States
Loyola Medical Center
Maywood, Illinois, United States
Washington University
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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ALD518-CLIN-010
Identifier Type: -
Identifier Source: org_study_id
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