A Study to Measure Hemolysis Markers in Subjects with Warm Autoimmune Hemolytic Anemia
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-009963
Sponsor Protocol Number: ANX-WAIHA-01
About this study
The purpose of this study is to measure and characterize markers of hemolysis (including but not limited to lactate dehydrogenase, indirect bilirubin, haptoglobin, and reticulocyte count), complement activation, and direct antiglobulin test (DAT), from subjects with Warm Autoimmune Hemolytic Anemia (wAIHA).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or female, ≥ 18 years of age at the time of informed consent.
- History of hemolysis that is not adequately controlled, as confirmed by enrolling investigator.
- Positive direct antiglobulin test (DAT) ≥ 1+ for C3d and IgG.
- Hgb level < 10.0 g /dL(pre-transfusion) with no alternative explanation for anemia apart from wAIHA.
- Evidence of active hemolysis based on at least one of the following:
- LDH above the ULN;
- Indirect bilirubin above the ULN;
- Haptoglobin below the LLN.
- Willing and able to give informed consent.
Exclusion Criteria:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ronald Go, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available