Clinical Trials HubDesigned for our wAIHA warriors

Our goal is to increase engagement and awareness of wAIHA with our patients, families, caregivers, and advocates. It is our hope more discoveries can contribute to improving the understanding and treatment of wAIHA.

Please contact us if you would like your research program or clinical trial to be published.

The Warrior Trial Hub

Our goal is to increase engagement and awareness of wAIHA with our patients, families, caregivers, and advocates. It is our hope more discoveries can contribute to improving the understanding and treatment of wAIHA.

Please contact us if you would like your research program or clinical trial to be published.

Current wAIHA clinical trials

Janssen Pharmaceuticals

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

Learn more

Incyte

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Learn more

Bioverativ

Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders

Learn more

Immunovant

Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia

Learn more

Rigel Pharmaceuticals

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Learn more

Apellis Pharmaceuticals

Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)

Learn more

Peking Union
Medical College Hospital

Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia (RRAIHA01)

Learn more

Running a trial that's not listed here?

If your team is running a clinical trial for wAIHA, get in touch with our team to get it listed here!

Learn more

Treatment options

These are the most common treatments used in managing the symptoms of wAIHA.
If you'd like to learn more about any of these options, please contact our team!

Corticosteroids

Prednisone:
Typically a high dose that is incrementally decreased with time

Splenectomy

Laparoscopic or open surgery performed to remove the spleen to stop early red blood cell loss

Severe form of wAIHA with continuous use of prednisone needed

Immunosuppressive Drugs

Cyclophosphamide:
Have helped when corticosteroids or splenectomy has not worked

Rituximab

Low-dose artificial antibody (biologic) that kills white blood cells that create antibodies that kill red blood cells

This can be used with corticosteroids and is beneficial for when prednisone does not work.

This can also be used before or after splenectomy.

Red blood cell
transfusion

Increases red blood cell count, but doesn’t treat root-cause of disease; only a short-term benefit.

Red blood cell
transfusion

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Red blood cell
transfusion

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Splenectomy

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Learn about clinical trials

Clinical trials don't have to be overwhelming. We're here to help guide you through the information that you may be curious about. If you'd like to learn more, or have a question we haven't answered here, let us know via email!

What is a clinical trial?

A clinical trial is a research study on novel tests, treatments on human participants led by scientific and medical individual(s) to add or improve the safety, efficiency, and quality of disease prevention and treatment as well as determine if new treatments/tests have negative side effects compared to treatments in place.

Clinical trials are conducted with thorough examination from design to review to completion. Scientific leaders of clinical trials are called Principal Investigators (PI). They are in charge of design, team (investigators), and overseeing the trial.

In order to conduct the study, they must have a sponsor (government agency, pharmaceutical company, non-profit organizations) to provide financial support. Before clinical trials can be executed, the protocol must be given approval first by the sponsor.
The next step of the review process involves approval from the Institutional Review Board (IRB), a group of 5 members selected by the health center composed of a scientist, non-scientist, non-health center member to ensure the protection of welfare and rights of participants.

Certain clinical trials who need further investigation are subject to Data and Safety Monitoring Boards (DSMBs) review. DSMBs comprises clinical trial experts who monitor clinical trials upon its approval to ensure protocol is being followed through examining data on clinical trial effectiveness, participant safety, and ethics of study.

Clinical trial phases

The four phases of a clinical trial are:

Phase 1
A small group of generally healthy participants (20-80) receives an experimental treatment to determine side effects and safety to discover appropriate drug dosage.

Phase 2
A larger group of participants (100-300) are tested to generate preliminary data on drug effectiveness, side effects, and safety.

Phase 3
A larger, more diverse range of participant populations (300-3,000) who receive differing drug combinations and dosages to determine safety and effectiveness. If results are favorable upon examination, the U.S. Food and Drug Administration (FDA) will proceed with clinical use for such test/treatment.

Phase 4
Upon FDA approval, such tests/treatments will be assessed for safety and efficiency amongst larger populations for extended periods of time.

The Steps In A Clinical Trial

Find an available clinical trial by navigating our Clinical Trials Hub.

Contact the clinical trial study coordinator. The study coordinator will gather your personal information as well as provide you with detailed information on the clinical trial.

Inform your healthcare provider about your interest in joining the clinical trial for communication between provider and clinical trial staff to ensure no health concerns.

Ask any questions you may have about the clinical trial and consent to participating in the study.

Participate in a screening to ensure qualification.

Once accepted, your first time (baseline) visit will be scheduled in which you will be provided physical and cognitive examinations.

You will be randomly assigned to a control or experimental group. The control group usually receives the current standard therapy -- in other words, they won't hand you sugar pills as placebos!

Continue doctor visits throughout your trial participation.

You and your family will be able to report any concerns, questions, or problems encountered to clinical trial staff.

Questions checklist

It can feel overwhelming to ask questions of medical professionals. To help you get started, we crafted these questions for you to consider asking. Think of others? Email us at team@waihawarriors.org!

General questions about the clinical trial
What is the study’s purpose and objectives?
How do the study’s risks, benefits, and side effects compare with my current treatment?
What tests, treatments, procedures will I be subject to in the study?
How frequently will I have to go into a clinic or hospital?
What is the setting of the study?
Will I have to be hospitalized?
What is the length of the study?

Expenses and reimbursement
Do I have any costs to participate in the trial?
How is my confidentiality/privacy ensured?
What services will be provided for transportation to the study center?
Are there any parts of the study that can be done at sites closer to me or with my regular doctor?
Will I get reimbursement for my expenses (i.e. housing, transportation)?
Will my insurance cover my expenses?
Will I have to be hospitalized?
What is the length of the study?

Care and lifestyle
Will the study interfere with my daily life?
Do I need insurance to participate in the study?
Who will be responsible for my medical care during the trial?
Will you notify my doctor about my participation in the clinical trial?
How will withdrawing from the study impact my care?
What can I do if I get injured, sick, or experience any negative side effects during the study?

After the trial
Will I receive a health follow-up after the trail?
What will the length (short-term or long-term) of follow up be?
If I see benefits from the trial, can I continue to receive the test/treatment after the clinical trial?
Will I get study results?

Download the checklist

Treatment options

These are the most common treatments used in managing the symptoms of wAIHA.
If you'd like to learn more about any of these options, please contact our team!

Corticosteroids

Prednisone:
Typically a high dose that is incrementally decreased with time

Splenectomy

Laparoscopic or open surgery performed to remove the spleen to stop early red blood cell loss

Severe form of wAIHA with continuous use of prednisone needed

Immunosuppressive Drugs

Cyclophosphamide:
Have helped when corticosteroids or splenectomy has not worked

Rituximab

Low-dose artificial antibody (biologic) that kills white blood cells that create antibodies that kill red blood cells

This can be used with corticosteroids and is beneficial for when prednisone does not work.

This can also be used before or after splenectomy.

Red blood cell
transfusion

Increases red blood cell count, but doesn’t treat root-cause of disease; only a short-term benefit.

Red blood cell
transfusion

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Red blood cell
transfusion

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Splenectomy

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.

Want to ask about something else?

If you need any additional support, please get in touch with our team.  We'd love to hear from you to see how we can be helpful to you and your warrior journey!

Get in touch