Two Dose Levels of Privigen in Pediatric CIDP
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- CSL Behring
- Study ID
- NCT03684018
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- IgPro10 — BIOLOGICALNormal human immunoglobulin G administered intravenously
Study Details
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
Key Dates
- Start date
- Feb 28, 2019
- Status verified
- May 2026
- Primary completion
- Dec 20, 2029
- Completion
- Dec 20, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: IgPro10 (dose level 1)
- Experimental: IgPro10 (dose level 2)
Primary Outcome Measure
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level [ Time Frame: Approximately 24 weeks ]
Central Contacts
- Trial Registration Coordinator6108784697
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | - |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | - |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242-1009 | - |
| Akron Children's Hospital | Akron | Ohio | 44647 | - |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Use Central Contact |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | - |
| Neurology Rare Disease Center | Flower Mound | Texas | 75028 | Use Central Contact |
| Children's Specialty Group | Norfolk | Virginia | 23507 | - |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Central Contact |