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Tyrosine Kinase Inhibitor

Fostamatinib for Autoimmune Hemolytic Anemia

Phase 3

Waitlist Available

Research Sponsored by Rigel Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks

Awards & highlights

Study Summary

This trial is looking at the long-term safety of a drug called fostamatinib in people with a condition called warm antibody autoimmune hemolytic anemia (wAIHA).

Who is the study for?

This trial is for individuals who have completed all 24 weeks of a previous study (C-935788-057) on warm antibody autoimmune hemolytic anemia (wAIHA). Participants must be able to consent and should not have dropped out before Week 24 of the prior study.Check my eligibility

What is being tested?

The trial is testing the long-term safety of a medication called Fostamatinib disodium in patients with wAIHA, which is a condition where the immune system destroys red blood cells causing anemia.See study design

What are the potential side effects?

While specific side effects are not listed here, generally, participants will be monitored for any adverse reactions over time to assess the safety profile of Fostamatinib disodium.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute Neutrophil Count (ANC)

Adverse Events

Blood Pressure

Secondary outcome measures

Achievement of Durable Hemoglobin Response

Corticosteroid dose

Total Duration of Response

Side effects data

From 2016 Phase 3 trial • 76 Patients • NCT02076399

41%

Diarrhoea

29%

Nausea

25%

Hypertension

18%

Dizziness

18%

Epistaxis

18%

Alanine aminotransferase increased

16%

Aspartate aminotransferase increased

14%

Headache

12%

Fatigue

10%

Upper respiratory tract infection

Dysgeusia

Chest pain

Rash

Constipation

Flatulence

Blood pressure increased

Urinary tract infection

Dyspnoea

Abdominal pain

Contusion

Vomiting

Anaemia

Pyrexia

Retinal Tear

Thrombocytopenia

Febrile Neutropenia

Vaginal Haemorrhage

Oropharyngeal pain

Syncope

Pneumonia

Immune Thrombocytopenic Purpura

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Recipient

Fostamatinib Recipient

Trial Design

1Treatment groups

Experimental Treatment

Group I: FostamatinibExperimental Treatment1 Intervention

Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fostamatinib disodium

2014

Completed Phase 3

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsLead Sponsor

31 Previous Clinical Trials

3,758 Total Patients Enrolled

Media Library

Fostamatinib Disodium (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04138927 — Phase 3

Autoimmune Hemolytic Anemia Research Study Groups: Fostamatinib

Autoimmune Hemolytic Anemia Clinical Trial 2023: Fostamatinib Disodium Highlights & Side Effects. Trial Name: NCT04138927 — Phase 3

Fostamatinib Disodium (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04138927 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific research has there been on Fostamatinib disodium?

"Fostamatinib disodium was first studied in 2016. In the 4 years since, there have been 30 completed clinical trials with 7 more active studies. Many of these are based in Los Angeles or Massachusetts."

Answered by AI

How can I sign up to take part in this research?

"Eligible participants must be between 18 and 100 years old, have anemia, hemolytic, and have completed all 24 weeks of participation in the study C-935788-057."

Answered by AI

Does this research allow people under the age of 50 to participate?

"According to the inclusion criteria listed on clinicaltrials.gov, people aged 18-100 are eligible for this particular trial. Out of the 296 total trials, 106 are for individuals under 18 and 190 are for seniors above 65."

Answered by AI

Is it possible to join this experiment yet?

"The clinicaltrials.gov website indicates that this research is not presently looking for volunteers. The study was first advertised on 10/30/2019 and received its most recent update on 3/2/2022. Although 265 other studies are actively recruiting participants."

Answered by AI

How many human test subjects are participating in this experiment?

"Unfortunately, this study is not looking for any more patients at the moment. The trial was first announced on October 30th, 2019 and has had several updates since then - with the most recent one being on March 2nd of this year. However, there are other trials which may be of interest; 258 studies related to anemia and hemolytic diseases are actively recruiting participants right now. Additionally, there are 7 clinical trials involving Fostamatinib disodium that need volunteers."

Answered by AI

Is this study taking place in a few select hospitals or is it more widespread?

"Enrolling patients can be found at University of Southern California in Los Angeles, Massachusetts General Hospital in Boston, John Hopkins Bayview Medical Center in Baltimore, and 10 other locations."

Answered by AI

When was the last time that Fostamatinib disodium received FDA approval?

"Fostamatinib disodium is a Phase 3 drug, meaning that there is some efficacy data and multiple rounds of safety data. Consequently, our team at Power has rated its safety as a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04138927.

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