NCT03684018 Two Dose Levels of Privigen in Pediatric CIDP
| NCT ID | NCT03684018 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | CSL Behring |
| Condition | Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-02-28 |
| Primary Completion | 2029-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2019-02-28 with a primary completion date of 2029-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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"
Contact & Investigator
Study Director
STUDY DIRECTOR
CSL Behring
Frequently Asked Questions
Who can join the NCT03684018 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03684018 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03684018 currently recruiting?
Yes, NCT03684018 is actively recruiting participants. Contact the research team at clinicaltrials@cslbehring.com for enrollment information.
Where is the NCT03684018 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Iowa City, United States, Akron, United States and 5 additional locations.
Who is sponsoring the NCT03684018 clinical trial?
NCT03684018 is sponsored by CSL Behring. The principal investigator is Study Director at CSL Behring. The trial plans to enroll 30 participants.