PANZYGA for Childhood CIDP
What You Need to Know Before You Apply
What is the purpose of this trial?
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for those who have received immunoglobulin or plasma exchange within eight weeks before the study. Additionally, patients on unstable doses of corticosteroids or rituximab may not be eligible. It's best to discuss your specific medications with the study team.
How is the drug Panzyga unique for treating childhood CIDP?
Panzyga is a high purity intravenous immunoglobulin (IVIG) that is stable for long periods and has a low level of additional plasma proteins, which may reduce the risk of side effects. It is designed to be similar to normal plasma, making it potentially safer and more effective for treating conditions like childhood CIDP.12345
What data supports the effectiveness of the drug Panzyga for treating childhood CIDP?
Are You a Good Fit for This Trial?
This trial is for children aged 2 to 17 with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They must have functional impairment due to CIDP and not have a history of inherited neuropathies, previous immunoglobulin therapy failure, or recent treatments that could affect the study. Participants need parental consent and may require birth control if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PANZYGA intravenously every four weeks over a period of sixteen weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Panzyga
Panzyga is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Octapharma
Lead Sponsor
Wolfgang Marguerre
Octapharma
Chief Executive Officer since 1983
MBA from INSEAD
Wolfgang Frenzel
Octapharma
Chief Medical Officer since 2010
MD from University of Vienna