Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Conditions
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
Interventions
BIOLOGICALIgPro10
Normal human immunoglobulin G administered intravenously
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level | Approximately 56 weeks | — |
| Rate of TEAEs per infusion | Approximately 56 weeks | — |
| Rate of mild, moderate, and severe TEAEs per infusion by dose level | Approximately 56 weeks | — |
| Percentage of subjects with serious TEAEs | Approximately 56 weeks | — |
| Rate of serious TEAEs per infusion | Approximately 56 weeks | — |
| Percentage of subjects with related TEAEs | Approximately 56 weeks | — |
| Rate of related TEAEs per infusion | Approximately 56 weeks | — |
| Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase | Approximately 24 weeks | — |
| Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase | Baseline and Approximately 24 weeks | The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death) |
| Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level | Approximately 24 weeks | CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit |
| Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level | Approximately 24 weeks | 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 |
| Time to CIDP relapse in Randomized Phase by dose level | Approximately 24 weeks | — |
| Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level | Approximately 24 weeks | CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline |
| Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level | Approximately 24 weeks | 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 |
| Time to CIDP Relapse in the Dose Exploration Phase by dose level | Approximately 24 weeks | — |
Countries
United States
Contacts
CONTACTTrial Registration Coordinator
STUDY_DIRECTORStudy Director
CSL Behring
Outcome results
None listed