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Immunoglobulin

PANZYGA for Childhood CIDP

Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥2 years and ≤17 years
Be younger than 18 years old
Must not have
Patients with a known history of inherited neuropathy or a family history of inherited neuropathy
Patients who have previously failed immunoglobulin therapy for CIDP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tested different doses of a drug to treat CIDP in children to see if it was safe and effective.

Who is the study for?
This trial is for children aged 2 to 17 with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They must have functional impairment due to CIDP and not have a history of inherited neuropathies, previous immunoglobulin therapy failure, or recent treatments that could affect the study. Participants need parental consent and may require birth control if applicable.
What is being tested?
The trial tests different dosing regimens of PANZYGA, an immunoglobulin therapy, in pediatric patients with CIDP. It aims to determine the safest and most effective dosage by monitoring how well the treatment works and any side effects it causes in these young patients.
What are the potential side effects?
While specific side effects are not listed here, PANZYGA as an immunoglobulin product can potentially cause allergic reactions, headaches, nausea, fever or chills. More serious but rare risks include blood clots or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I or my family have a history of inherited nerve disease.
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I have CIDP and did not respond to immunoglobulin therapy.
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I have had a deep vein thrombosis in the last year or a pulmonary embolism at some point.
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My liver and kidney function tests are within normal limits.
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I was diagnosed with CIDP but currently have no symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Change in CIDP Baseline
Secondary study objectives
CIDP Relapse
Percentage of Patients With Good/Excellent Response
Time to CIDP Relapse

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

2Treatment groups
Experimental Treatment
Group I: Panzyga Low DoseExperimental Treatment1 Intervention
1.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.
Group II: Panzyga High DoseExperimental Treatment1 Intervention
2.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.
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
11,227 Total Patients Enrolled
~17 spots leftby Jun 2026
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