NCT04256148WithdrawnPhase 2
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
Study Overview
Brief 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).
Detailed Description
This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Active Comparator
Intervention: Placebo (Other)
ALXN1830 Dosing Regimen 3
Experimental
Intervention: ALXN1830 (Biological)
ALXN1830 Dosing Regimen 2
Experimental
Intervention: ALXN1830 (Biological)
ALXN1830 Dosing Regimen 1
Experimental
Intervention: ALXN1830 (Biological)
Outcomes
Primary Outcomes
Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
Time Frame: Baseline (Day 1) through Day 92
Secondary Outcomes
- Total Number Of Units Of Packed Red Blood Cells (pRBCs) Transfused(Day 15 through Day 92)
- Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via Functional Assessment Of Cancer Therapy Anemia (FACT-AN) Questionnaire(Baseline, Day 92)
- Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire(Baseline, Day 92)
- Number Of Weekly Hgb Measurements With Change From Baseline ≥ 2 g/dL(Day 1 through Day 92)
- Number Of Participants Needing New WAIHA Rescue Medication Or Increase In Dose Of WAIHA Medication(Day 15 through Day 92)
Investigators
Study Sites (1)
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