Two Dose Levels of Privigen in Pediatric CIDP

Launched by CSL BEHRING · Sep 24, 2018

Keywords

ClinConnect Summary

This clinical trial, titled “Two Dose Levels of Privigen in Pediatric CIDP,” is studying the effects of a medication called Privigen on children and teenagers aged 2 to 17 who have been diagnosed with a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and difficulty moving. The trial aims to find out which of the two dose levels of Privigen works best for treating CIDP in young patients, whether they have received this treatment before or not.

To be eligible to participate in this study, children must be between 2 and 17 years old and have symptoms of CIDP. However, children who do not have CIDP symptoms, have a family history of certain nerve disorders, or have specific health issues may not be able to join the study. Participants can expect to receive one of the two dose levels of Privigen and will be monitored closely by the medical team throughout the trial to ensure their safety and track how well the treatment is working. This study is currently recruiting participants, and it is important for families to discuss any questions or concerns with their healthcare provider.

Gender

ALL

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"