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Immunoglobulin

PANZYGA for Chronic ITP

Phase 4
Waitlist Available
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females and males aged from ≥1 year to <18 years old
Confirmed diagnosis of Chronic Immune Thrombocytopenia (ITP) according to American Society of Hematology (ASH) 2019 guidelines
Must not have
Unable or unwilling to comply with the study protocol
Splenectomy in the previous 3 months or planned splenectomy throughout the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 37 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

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

Who is the study for?
This study is for children and teenagers aged 1 to less than 18 with chronic ITP, a condition where the immune system destroys platelets. They must have low platelet counts and agree to use birth control if sexually active. Those with recent surgeries, certain infections like HIV or hepatitis, other causes of low platelets, unstable medication doses, severe liver/kidney disease, drug/alcohol abuse history, nonresponse to similar treatments or major bleeding can't join.
What is being tested?
The trial tests PANZYGA's effectiveness and safety in young patients with chronic ITP. It's an open-label Phase 4 study meaning everyone knows they're getting PANZYGA without any placebo group involved. The goal is to see how well it increases their platelet counts and assess any potential risks.
What are the potential side effects?
PANZYGA may cause allergic reactions or infusion-related side effects such as headache or nausea. There could also be a risk of blood clots especially in those who already have factors that increase this risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 17 years old.
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I have been diagnosed with Chronic ITP according to ASH 2019 guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing and able to follow the study rules.
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I have had my spleen removed in the last 3 months or will have it removed.
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I am currently experiencing a significant bleeding episode.
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I have low platelet counts not caused by AIDS, lupus, drugs, or a congenital condition.
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I am not pregnant or nursing.
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I have not had emergency surgery in the last 4 weeks.
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I have or might have HIV, HBV, or HCV.
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I have Evans syndrome with at least two symptoms: low platelets, anemia, or low neutrophil count.
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My liver and kidney function tests are within normal limits.
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My condition did not improve after treatment with IGIV or anti-D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 37 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 37 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Platelet Count Increase
Secondary study objectives
Days to Reach Platelet Count of at Least 50x10^9/L
Duration of Platelet Response
Maximum Platelet Count

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: PanzygaExperimental Treatment1 Intervention
Panzyga
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panzyga
2011
Completed Phase 3
~420

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor
85 Previous Clinical Trials
11,251 Total Patients Enrolled

Media Library

Panzyga (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT03866798 — Phase 4
Thrombocytopenic Purpura Research Study Groups: Panzyga
Thrombocytopenic Purpura Clinical Trial 2023: Panzyga Highlights & Side Effects. Trial Name: NCT03866798 — Phase 4
Panzyga (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03866798 — Phase 4
~1 spots leftby Dec 2025
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