ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia

Phase 1

• Conditions: Warm Autoimmune Hemolytic Anemia (WAIHA); MedDRA version: 20.0Level: LLTClassification code 10003825Term: Autoimmune hemolytic anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-001211-90-IT
• Lead Sponsor: ALEXION PHARMACEUTICALS INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent
2. Diagnosed with primary or secondary WAIHA at least 6 weeks prior to Screening
3. Failed or have not tolerated at least one prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
4. Hemoglobin < 10 g/dL and = 6 g/dL at Screening
5. Positive direct antiglobulin test (Coombs) (IgG positive who are positive or negative for the presence of complement C3 [C3]) at Screening
6. Evidence of active hemolysis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Packed RBC or whole blood transfusions in the 2 weeks prior to Screening
2. History of cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria
3. History of drug-induced or infection-related immune hemolytic anemia
4. Iron, folic acid, or vitamin B12 deficiency
5. Participants with Evan's syndrome
6. History of leukemia, Hodgkin, or non Hodgkin lymphoma
7. History of solid malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancy for which the participant had not been disease free for at least 5 years
8. Active infection or history of recurrent systemic infections in the 2 years prior to Screening
10. Systemic lupus erythematosus (SLE) or other autoimmune disease that is not stable or not well controlled on current therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified