Two Dose Levels of Privigen in Pediatric CIDP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-17
SponsorCSL Behring
About this trial
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
This trial does not accept healthy volunteersQualifiers
- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Disqualifiers
- Absence of CIDP symptoms
-History or family history of inherited neuropathy
-Diagnosed developmental delay or regression
-History of thrombotic episode
Trial design
Design model
Parallel
Treatments tested in this trial
IgPro10
Biological/VaccineNormal human immunoglobulin G administered intravenously
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: IgPro10 (dose level 1)Experimental treatment 1 intervention
Group B: IgPro10 (dose level 2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Approximately 24 weeksSecondary outcomes
1
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Time frame
Approximately 56 weeks2
Rate of TEAEs per infusion
Time frame
Approximately 56 weeks3
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Time frame
Approximately 56 weeks4
Percentage of subjects with serious TEAEs
Time frame
Approximately 56 weeksSponsors and contacts
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Source ClinicalTrials.gov