Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Phase 4NCT03684018
Two Dose Levels of Privigen in Pediatric CIDP
A Phase 4 study testing IgPro10 in people with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by CSL Behring at 9 sites in United States.
Trial summary
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- IgPro10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Feb 2019to 20 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Who cannot join
- - Absence of CIDP symptoms
- -History or family history of inherited neuropathy
- -Diagnosed developmental delay or regression
- -History of thrombotic episode
- -Known or suspected hypersensitivity to Privigen
- -Known allergic or other severe reactions to blood products
- -Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study
- -Pregnant or breastfeeding mother"
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 3 recruiting
- Withdrawn
Akron Children's Hospital
Akron, Ohio, 44647
- Recruiting
Neurology Rare Disease Center
Flower Mound, Texas, 75028
Use Central Contact
- Withdrawn
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
- Withdrawn
Children's Hospital of Los Angeles
Los Angeles, California, 90027
- Withdrawn
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
- Completed
Children's Specialty Group
Norfolk, Virginia, 23507
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Use Central Contact
- Completed
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Central Contact
About this study
Official title: Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
- Being tested
- IgPro10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgPro10Biological
Also called Privigen
Normal human immunoglobulin G administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| IgPro10 (dose level 1) | Experimental | Not described Receives: Biological: IgPro10 |
| IgPro10 (dose level 2) | Experimental | Not described Receives: Biological: IgPro10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase
Measured: Approximately 24 weeks
Secondary outcomes (15)
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Measured: Approximately 56 weeks
Rate of TEAEs per infusion
Measured: Approximately 56 weeks
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Measured: Approximately 56 weeks
Percentage of subjects with serious TEAEs
Measured: Approximately 56 weeks
Rate of serious TEAEs per infusion
Measured: Approximately 56 weeks
Percentage of subjects with related TEAEs
Measured: Approximately 56 weeks
Rate of related TEAEs per infusion
Measured: Approximately 56 weeks
Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase
Measured: Approximately 24 weeks
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase
The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)
Measured: Baseline and Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level
CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit
Measured: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level
CIDP recovery in the Randomized Phase, defined as decrease in mRS score as comparedto baseline AND mRS score of 1 or 0 at end of Randomized Phase
Measured: Approximately 24 weeks
Time to CIDP relapse in Randomized Phase by dose level
Measured: Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level
CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline
Measured: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level
CIDP recovery in the Dose Exploration Phase, defined as decrease in mRS score compared to baseline AND mRS score of 1 or 0 at end of DEP
Measured: Approximately 24 weeks
Time to CIDP Relapse in the Dose Exploration Phase by dose level
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start28 Feb 2019
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684018
- Sponsor's protocol ID
- IgPro10_4002
- Other IDs
- 2018-003430-33, 2018
- Status last verified
- May 2026
- First submitted
- 24 Sep 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.
PubMed 38353301
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
- ClinicalTrials.gov ID
- NCT03684018
- Acronym / sponsor ID
- IgPro10_4002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgPro10 (dose level 1) | Experimental | Biological: IgPro10 |
| IgPro10 (dose level 2) | Experimental | Biological: IgPro10 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- - Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Key exclusion criteria (8 listed)
- - Absence of CIDP symptoms
- -History or family history of inherited neuropathy
- -Diagnosed developmental delay or regression
- -History of thrombotic episode
- -Known or suspected hypersensitivity to Privigen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgPro10Also: PrivigenNormal human immunoglobulin G administered intravenously | Biological | IgPro10 (dose level 1), IgPro10 (dose level 2) |
Primary outcome
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
Time frame: Approximately 24 weeks
CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase
15 secondary outcomes
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Time frame: Approximately 56 weeks
Rate of TEAEs per infusion
Time frame: Approximately 56 weeks
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Time frame: Approximately 56 weeks
Percentage of subjects with serious TEAEs
Time frame: Approximately 56 weeks
Rate of serious TEAEs per infusion
Time frame: Approximately 56 weeks
Percentage of subjects with related TEAEs
Time frame: Approximately 56 weeks
Rate of related TEAEs per infusion
Time frame: Approximately 56 weeks
Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase
Time frame: Approximately 24 weeks
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase
Time frame: Baseline and Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level
Time frame: Approximately 24 weeks
Time to CIDP relapse in Randomized Phase by dose level
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level
Time frame: Approximately 24 weeks
Time to CIDP Relapse in the Dose Exploration Phase by dose level
Time frame: Approximately 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 38353301Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
CSL Behring
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IgPro10 in people with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by CSL Behring at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Registration Coordinator (6108784697 ext. +1, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level (time frame: Approximately 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.