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Immunoglobulin

IgPro10 Dosage for Childhood CIDP

Phase 4
Recruiting
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Be younger than 18 years old
Must not have
History or family history of inherited neuropathy
Absence of CIDP symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing two different doses of a medication for kids with a rare disease called CIDP. The trial is open to kids who haven't tried this medication before, and also to kids who have tried it before but at a different dose.

Who is the study for?
This trial is for children and teenagers aged 2 to 17 with confirmed or possible Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They can be new or past users of IVIG therapy. Those ineligible include individuals without CIDP symptoms, a history of inherited neuropathies, developmental delays, severe reactions to blood products, pregnant/breastfeeding females, and those not using contraception.
What is being tested?
The study is testing two different doses of IgPro10 (Privigen) in young patients with CIDP. It's an open-label trial meaning everyone knows what treatment they're getting. The goal is to see how well the different doses work and how safe they are over time.
What are the potential side effects?
Possible side effects from Privigen may include allergic reactions, headache, nausea, fatigue, pain at the infusion site or more serious ones like blood clots. Each child might experience these differently.

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 with a diagnosis or suspicion of CIDP.

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 damage.
Select...
I do not have symptoms of CIDP.
Select...
I am not using or willing to use birth control and am not abstaining from sex.
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I have had a blood clot in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 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
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
Secondary study objectives
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level
+2 more

Side effects data

From 2014 Phase 4 trial • 57 Patients • NCT01390649
30%
Headache
5%
Pyrexia
2%
Immune Thrombocytopenic Purpura
100%
80%
60%
40%
20%
0%
Study treatment Arm
IgPro10

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: IgPro10 (dose level 2)Experimental Treatment1 Intervention
Group II: IgPro10 (dose level 1)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IgPro10
2012
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
198 Previous Clinical Trials
1,204,791 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,277 Previous Clinical Trials
499,304 Total Patients Enrolled

Media Library

IgPro10 (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT03684018 — Phase 4
Childhood CIDP Research Study Groups: IgPro10 (dose level 2), IgPro10 (dose level 1)
Childhood CIDP Clinical Trial 2023: IgPro10 Highlights & Side Effects. Trial Name: NCT03684018 — Phase 4
IgPro10 (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03684018 — Phase 4
~14 spots leftby Dec 2029
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