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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the long-term safety of a medication for patients with a condition where their immune system attacks their own red blood cells. The medication works by calming down the immune system to stop this attack. It has shown promising results in treating several autoimmune diseases.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Neutrophil Count (ANC)

Adverse Events

Blood Pressure

Secondary study objectives

Corticosteroid dose

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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