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

Conditions

• Pediatric Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Panzyga — DRUG
  PANZYGA is a human immunoglobin solution with 10% protein content for intravenous (IV) administration.

Study Details

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

Key Dates

Start date

Oct 1, 2023

Status verified

Jun 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Panzyga High Dose
  2.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.
• Experimental: Panzyga Low Dose
  1.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.

Primary Outcome Measure

Change in CIDP Baseline [ Time Frame: Up to 24 weeks ]

Central Contacts

• Patrick Murphy
  866-337-1868
  [email protected]

Locations (6)

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