ClinicalTrials.gov record NCT04138927

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.The registry record was last updated on Mar 17, 2022, about 4 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.

Age18 years old to 100 years old

SexAll

LocationAustralia, Austria, Belarus, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Italy, Netherlands, Norway, Russia, Serbia, Spain, Ukraine, United Kingdom, United States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 3 extension follows adults with warm antibody autoimmune hemolytic anemia who completed 24 weeks in study C-935788-057. Participants receive fostamatinib and are monitored for safety, blood counts, and hemoglobin response. Data are collected during treatment for up to 104 weeks.

What it is studying. The study is testing the long-term safety of fostamatinib in people with warm antibody autoimmune hemolytic anemia (wAIHA). It tracks adverse events, changes in blood pressure and absolute neutrophil count over time, and collects measures of hemoglobin response durability, total duration of response, and corticosteroid dose while participants take the drug.

What the researchers hope to learn. Scientific goals: evaluate long-term safety of fostamatinib in wAIHA; measure incidence, frequency, seriousness, and severity of adverse events; track blood pressure and absolute neutrophil count over 104 weeks; assess durable hemoglobin response, total duration of response, and changes in corticosteroid dose.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The primary objective of this study is:

To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Fostamatinib disodium

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion criteria

Any subject who discontinued participation in Study C-935788-057 prior to Week 24.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive oral fostamatinib and are followed for safety measures for up to 104 weeks. New entrants generally start fostamatinib 100 mg twice daily with a possible increase to 150 mg twice daily at Week 4 if tolerated; people who achieved a hemoglobin response in the prior study continue the dose/regimen they were on at Week 22. The study includes regular safety monitoring such as reporting adverse events, blood pressure checks, and blood tests including absolute neutrophil count, and tracking corticosteroid dose.

How the study is structured. Open-label, single-group Phase 3 extension. Participants receive fostamatinib. Those who had a hemoglobin response in the parent study continue at their Week 22 dose; other entrants start fostamatinib 100 mg by mouth twice daily, with an option to increase to 150 mg twice daily from Week 4 if tolerated per the Investigator. Safety and lab measures are collected during treatment for up to 104 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in Australia, Austria, Belarus, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Italy, Netherlands, Norway, Russia, Serbia, Spain, Ukraine, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Oct 30, 2019
Primary completion: April 2024 (estimated)
Study completion: April 2024 (estimated)
Target enrollment: 90 participants (estimated)
Last updated on registry: Mar 17, 2022
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Rigel Pharmaceuticals

Participating sites (37)

Filter by country:

University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
Los Angeles, California, 90033 · United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502 · United States
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007 · United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21205 · United States
Massachusetts General Hospital
Boston, Massachusetts, 02114 · United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169 · United States
American Oncology Network Vista Oncology Division
Olympia, Washington, 98506 · United States
University of Washington
Seattle, Washington, 98109 · United States
Princess Alexandra Hospital - Cancer Trials Unit
Brisbane, Queensland, 4201 · Australia
The Alfred Hospital
Melbourne, Victoria, 3004 · Australia

Terms used on this page · explanations by MedicalUpdates.ai

primary objective: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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