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Immunoglobulin

PANZYGA for Childhood CIDP

Phase 3

Recruiting

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥2 years and ≤17 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

Study Summary

This trial tested different doses of a drug to treat CIDP in children to see if it was safe and effective.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial tests different dosing regimens of PANZYGA, an immunoglobulin therapy, in pediatric patients with CIDP. It aims to determine the safest and most effective dosage by monitoring how well the treatment works and any side effects it causes in these young patients.See study design

What are the potential side effects?

While specific side effects are not listed here, PANZYGA as an immunoglobulin product can potentially cause allergic reactions, headaches, nausea, fever or chills. More serious but rare risks include blood clots or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in CIDP Baseline

Secondary outcome measures

CIDP Relapse

Percentage of Patients With Good/Excellent Response

Time to CIDP Relapse

Trial Design

2Treatment groups

Experimental Treatment

Group I: Panzyga Low DoseExperimental Treatment1 Intervention

1.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.

Group II: Panzyga High DoseExperimental Treatment1 Intervention

2.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panzyga

2011

N/A

~350

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor

84 Previous Clinical Trials

7,828 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for participation in this trial below 35 years old?

"This clinical trial seeks participants that are aged between 2 to 17 years old. Additionally, 18 trials have been established for minors and 48 studies are geared towards seniors over 65."

Answered by AI

Has Panzyga High Dose earned governmental recognition for its efficacy?

"Our team at Power assigned Panzyga High Dose a safety rating of 3 due to the existence of several clinical trials which have demonstrated its efficacy and safety."

Answered by AI

Are there additional investigations regarding the usage of Panzyga High Dose?

"At this moment, 29 investigations are ongoing concerning Panzyga High Dose. Of these trials, 16 have reached Phase 3 status. Orange, Massachusetts is the primary host of clinical trails for this drug; however, there exist 447 additional locations conducting studies related to it."

Answered by AI

Is enrollment available for this medical experimentation?

"Unfortunately, this trial is not currently admitting volunteers. It was initially announced on the 1st of November 2023 and edited for the last time on October 2nd 2023. If you would like to explore other options, presently there are 35 trials recruiting patients with childhood cidp and 29 clinical studies that accept participants for Panzyga High Dose intervention."

Answered by AI

What health conditions are typically remedied with Panzyga High Dose?

"Bruton's agammaglobulinemia is often managed with Panzyga High Dose, and this medication may also help those afflicted with PIDs, other forms of agammaglobulinemia, or CIDP."

Answered by AI

How many participants are actively engaging in this clinical trial?

"At this moment, the clinical trial is not looking for additional patients. It was first posted on November 1st 2023 and had its most recent alteration on October 2nd 2023. If you are searching for other studies, there are 35 trials involving childhood cidp that are actively enrolling and 29 different studies testing Panzyga High Dose with open spots available."

Answered by AI

Who is eligible to enroll in this clinical investigation?

"This trial is seeking 30 minors that have been diagnosed with CIDP. In order to participate, individuals must meet the following criteria: between 2 and 17 years of age; definite or probable diagnosis as determined by ENMC guidelines; functional disability marked by an mRS score greater than 2 but less than 5; and either written consent provided by their parent/legal guardian or assent given based on IEC/IRB regulations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients

2023. "Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929236.

All > Neuropathy > Cidp