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New treatment option for Autoimmune Hemolytic Anemia (AIHA)
Official title Orelabrutinib in the Treatment of Relapsed/Refractory AIHA
ClinicalTrials.gov ID: NCT07453368
What this study is testing
What is Orelabrutinib-50?
Orelabrutinib-50 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for autoimmune hemolytic anemia (aiha).
Also referred to as wAIHA-A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age ≥ 18 years.
- Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative...
- For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg/kg/day), intolerance, or relapse (after...
- For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g/L or recurrence of...
- Baseline liver and kidney function (ALT, Cr) within 2 times the upper limit of normal (elevated AST, LDH, Bil due to hemolysis are not used as...
You likely can't join if
- Active involvement of other major organs due to connective tissue disease.
- Uncontrolled infection or bleeding per standard treatment.
- Uncontrolled active HIV, HCV, or HBV infection per standard treatment.
- Concurrent advanced uncontrolled malignancy, lymphoma.
- Presence of other uncorrected types of anemia at screening, such as nutritional anemia, thalassemia, etc.
- Currently receiving glucocorticoid therapy at screening and unable to discontinue or taper to ≤ 15 mg/day (prednisone equivalent) within 1 week...
See the full eligibility criteria
- Age ≥ 18 years.
- Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative disorder (LPD). If secondary, CTD should have no indication for...
- For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg/kg/day), intolerance, or relapse (after initial response, hemoglobin drop ≥20 g/L or requiring re-initiation of...
- For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g/L or recurrence of vascular symptoms, or requiring re-initiation of immunosuppressive...
- Baseline liver and kidney function (ALT, Cr) within 2 times the upper limit of normal (elevated AST, LDH, Bil due to hemolysis are not used as indicators for liver function assessment).
- Agreement to sign the informed consent form.
- Active involvement of other major organs due to connective tissue disease.
- Uncontrolled infection or bleeding per standard treatment.
- Uncontrolled active HIV, HCV, or HBV infection per standard treatment.
- Concurrent advanced uncontrolled malignancy, lymphoma.
- Presence of other uncorrected types of anemia at screening, such as nutritional anemia, thalassemia, etc.
- Currently receiving glucocorticoid therapy at screening and unable to discontinue or taper to ≤ 15 mg/day (prednisone equivalent) within 1 week before enrollment.
- Currently receiving treatment with medications such as cyclosporine, tacrolimus, sirolimus, cyclophosphamide, azathioprine, stanozolol, testosterone undecanoate, danazol, etc., at screening, and the treatment duration...
- Last dose of rituximab \< 3 months prior to enrollment.
- Prior treatment with any BTK inhibitor.
- Liver cirrhosis or portal hypertension.
- Pregnant or breastfeeding women.
- Participation in another clinical trial within the past 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.