Two Dose Levels of Privigen in Pediatric CIDP

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03684018
• Date of registration: 24/09/2018
• Prospective Registration: Yes
• Primary sponsor: CSL Behring
• Public title: Two Dose Levels of Privigen in Pediatric CIDP
• Scientific title: Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
• Date of first enrolment: February 28, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03684018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Study Director
• Affiliation: CSL Behring

• Name: Trial Registration Coordinator

Key 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"



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Intervention(s)

Biological: IgPro10

Primary Outcome(s)

Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level [Time Frame: Approximately 24 weeks]

Secondary Outcome(s)

Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase [Time Frame: Baseline and Approximately 24 weeks]

Time to CIDP Relapse in the Dose Exploration Phase by dose level [Time Frame: Approximately 24 weeks]

Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level [Time Frame: Approximately 24 weeks]

Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level [Time Frame: Approximately 24 weeks]

Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase [Time Frame: Approximately 24 weeks]

Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level [Time Frame: Approximately 24 weeks]

Time to CIDP relapse in Randomized Phase by dose level [Time Frame: Approximately 24 weeks]

Percentage of subjects with related TEAEs [Time Frame: Approximately 56 weeks]

Percentage of subjects with serious TEAEs [Time Frame: Approximately 56 weeks]

Rate of mild, moderate, and severe TEAEs per infusion by dose level [Time Frame: Approximately 56 weeks]

Rate of TEAEs per infusion [Time Frame: Approximately 56 weeks]

Rate of serious TEAEs per infusion [Time Frame: Approximately 56 weeks]

Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level [Time Frame: Approximately 24 weeks]

Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level [Time Frame: Approximately 56 weeks]

Rate of related TEAEs per infusion [Time Frame: Approximately 56 weeks]

Secondary ID(s)

2018-003430-33

IgPro10_4002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors