WithdrawnPhase 2

ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

Stopped: Study is withdrawn due to the global impact of the COVID-19 pandemic.

United States0Started 2021-07

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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 Key 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline

Timeframe: Baseline (Day 1) through Day 92

Trial details

NCT IDNCT04256148

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-30

View on ClinicalTrials.gov More Warm Autoimmune Hemolytic Anemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.