All > Thrombocytopenia

Panzyga for Chronic Idiopathic Thrombocytopenic Purpura

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Chronic Idiopathic Thrombocytopenic PurpuraPanzyga - Biological
Eligibility
1 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for chronic ITP in children to see if it is effective and safe.

Eligible Conditions
  • Chronic Idiopathic Thrombocytopenic Purpura

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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Acetaminophen and Diphenhydramine Only Product
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fostamatinib

Study Objectives

2 Primary · 25 Secondary · Reporting Duration: 39 days

32 Days
Platelet Count measurement
32 days
Duration of Platelet Response
39 days
Alanine Transaminase
AST (Aspartate Aminotransferase)
Adverse Events
BUN (blood urea nitrogen)
Bilirubin Levels
Blood Pressure
Calcium
Complete Blood Count
Creatinine
Heart Rate
Hematocrit
Hemoglobin
LDH (lactase dehydrogenase)
Platelet Count measurement
Maximum platelet count recorded during the study
Physical Examinations
Platelet Counts
Potassium
Respiratory Rate
Reticulocytes
Sodium
Temperature
Leukocytes
8 Days
Increasing the platelet count in pediatric patients with chronic ITP
Platelet Count

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
rituxan
1
Acetaminophen and Diphenhydramine Only Product
2
fostamatinib

Trial Design

1 Treatment Group

Panzyga
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Panzyga · No Placebo Group · Phase 4

Panzyga
Biological
Experimental Group · 1 Intervention: Panzyga · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 39 days

Who is running the clinical trial?

OctapharmaLead Sponsor
80 Previous Clinical Trials
7,392 Total Patients Enrolled

Eligibility Criteria

Age 1 - 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Platelets count <30x10^9/L at the Baseline Visit.
You voluntarily give informed consent and/or assent.
References

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