ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

Study Identifier:
ALXN1830-WAI-201
ClinicalTrials.gov Identifier:
NCT04256148
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Warm Autoimmune Hemolytic Anemia
Study Drug
  • Biological: ALXN1830
Date
Jul 2021 - Oct 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
  • 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
  • Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Warm Autoimmune Hemolytic Anemia
Study Drug
  • Biological: ALXN1830
Date
Jul 2021 - Oct 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
  • 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
  • Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test

Protocol Summary

The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).

Trial Locations

Location
Status
Location
Alexion Study Site
Whittier, California, United States, 90602
Status
N/A