Testing two doses of Privigen for children with CIDP
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
This study is testing two different doses of Privigen to see if it helps children aged 2 to 17 with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | CSL Behring Industry-sponsored |
| Locations | 9 sites (Phoenix, Arizona and 8 other locations) |
| Trial ID | NCT03684018 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different dose levels of Privigen in pediatric patients aged 2 to 17 years who have confirmed or possible Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is a randomized, open-label, multicenter trial that includes participants who have either been previously treated with intravenous immunoglobulin (IVIG) or are unexposed to it. The goal is to evaluate the safety and efficacy of IgPro10 in this specific population.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years with confirmed or possible CIDP.
Not a fit: Patients without CIDP symptoms or those with a history of certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for children suffering from CIDP, potentially improving their quality of life.
How similar studies have performed: Other studies involving IVIG treatments have shown positive outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP. Exclusion Criteria: * \- 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"
Where this trial is running
Phoenix, Arizona and 8 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Completed)
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Withdrawn)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Withdrawn)
- Akron Children's Hospital — Akron, Ohio, United States (Withdrawn)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States (Withdrawn)
- Neurology Rare Disease Center — Denton, Texas, United States (Recruiting)
- Children's Specialty Group — Norfolk, Virginia, United States (Completed)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1 610-878-4697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.