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Initiating treatment with fostamatinib as second-line therapy for Thrombocytopenic Purpura

N/A
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 12-month observation period
Awards & highlights

Study Summary

Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).

Eligible Conditions
  • Thrombocytopenic Purpura

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month observation period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month observation period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fostamatinib dosing
ITP-PAQ Quality of life measure
Platelet Count measurement
+5 more

Side effects data

From 2013 Phase 2 trial • 101 Patients • NCT01499303
24%
BLOOD ALKALINE PHOSPHATASE INCREASED
24%
NEUTROPENIA
24%
THROMBOCYTOPENIA
19%
NAUSEA
19%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
FATIGUE
19%
CONSTIPATION
19%
BACK PAIN
19%
PYREXIA
19%
COUGH
14%
DIARRHOEA
14%
DYSPNOEA
14%
BLOOD CREATININE INCREASED
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
BLOOD BILIRUBIN INCREASED
10%
ANAEMIA
10%
ABDOMINAL DISTENSION
10%
HEADACHE
10%
OEDEMA PERIPHERAL
10%
BLOOD UREA INCREASED
10%
HYPOTENSION
10%
ARTHRALGIA
10%
ANXIETY
10%
NEUTROPHIL COUNT DECREASED
5%
HYPERTENSION
5%
ABDOMINAL PAIN
5%
WHITE BLOOD CELL COUNT DECREASED
5%
HYPONATRAEMIA
5%
BLOOD LACTATE DEHYDROGENASE INCREASED
5%
MYALGIA
5%
NEUTROPENIC SEPSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
100mg BID
200mg BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treated with fostamatinib for at least 12 weeks as second-line therapyExperimental Treatment1 Intervention
Group II: Initiating treatment with fostamatinib as second-line therapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fostamatinib
FDA approved

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
3,832 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
2021. "Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04904276.
~4 spots leftby May 2025
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