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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 56 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 2 and 17 years old with a diagnosis or suspicion of CIDP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
Secondary outcome measures
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
+12 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

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
194 Previous Clinical Trials
1,211,192 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,203 Previous Clinical Trials
489,549 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the government regulations concerning the use of IgPro10?

"Since this is a phase 4 trial, meaning that the treatment has already been approved, our team at Power estimates the safety of IgPro10 to be a 3."

Answered by AI

Are there other examples of IgPro10 being studied in a clinical setting?

"IgPro10 was first studied in 2008 at Montefiore Medical Center. As of now, there have been 166 completed studies. 37 clinical trials are still recruiting patients, a number of them based in San Francisco."

Answered by AI

Are investigators still recruiting participants for this research project?

"According to the latest update on clinicaltrials.gov, this clinical trial is looking for participants. The trial was originally posted on February 28th, 2019 and was most recently updated on August 24th, 2022."

Answered by AI

Are there any inclusionary or exclusionary factors for potential participants of this research?

"Researchers are seeking 30 individuals, that are children or adolescents, to participate in this study. In order to qualify, potential participants must have a diagnosis of pediatric chronic inflammatory demyelinating polyneuropathy (cidp) and meet the following additional criteria: Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP."

Answered by AI

For what purpose is IgPro10 most often prescribed?

"IgPro10 is an effective medical intervention for treating bruton's agammaglobulinemia, primary immunodeficiencies (pid), and agammaglobulinemia."

Answered by AI

Are individuals aged 20 or more eligible to enroll in this clinical trial?

"According to the rules for who can participate in this trial, the minimum age is 2 and the maximum age is 17."

Answered by AI

Is this clinical trial being conducted in more than one hospital in our state?

"There are 10 sites running this study at the moment, with locations in San Francisco, Norfolk, Iowa City and other places. If you choose to enroll in the study, try to select the site that is nearest to you to limit the amount of travel required."

Answered by AI
~16 spots leftby Dec 2029