ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
NCT ID: NCT04256148
Last Updated: 2020-07-13
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WITHDRAWN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
INTERVENTIONAL
2021-07-31
2023-04-30
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
TRIPLE
Study Groups
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ALXN1830 Dosing Regimen 1
ALXN1830
Administered via intravenous (IV) infusion
ALXN1830 Dosing Regimen 2
ALXN1830
Administered via intravenous (IV) infusion
ALXN1830 Dosing Regimen 3
ALXN1830
Administered via intravenous (IV) infusion
Placebo
Placebo
Matching placebo (sterile liquid diluent) administered via IV infusion
Interventions
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ALXN1830
Administered via intravenous (IV) infusion
Placebo
Matching placebo (sterile liquid diluent) administered via IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed or not tolerated at least 1 prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
* Hemoglobin \< 10 g/dL and ≥ 6 g/dL
* Positive direct antiglobulin test (Coombs) (IgG positive, complement C3 \[C3\] positive or negative)
* Evidence of active hemolysis including any of the following: a) Lactate dehydrogenase (LDH) \> upper limit of normal (ULN), b) Haptoglobin \< lower limit of normal (LLN), c) Indirect bilirubin \> ULN
* Total IgG \> 500 mg/dL
Exclusion Criteria
* Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Alexion Study Site
Whittier, California, United States
Countries
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Other Identifiers
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ALXN1830-WAI-201
Identifier Type: -
Identifier Source: org_study_id
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