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IVIG vs SCIG in CIDP
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.
Conditions:
🦠 CIDP 🦠 Immunoglobulin Deficiency 🦠 Chronic Inflammatory Demyelinating Polyneuropathy
🗓️ Study Start (Actual) 11 September 2022
🗓️ Primary Completion (Estimated) 18 October 2024
✅ Study Completion (Estimated) 18 October 2024
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 New Brunswick, New Jersey, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
    • * 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.

    Exclusion Criteria:

    • * Patients receiving IVIG for indications other than CIDP will be excluded.
    • * Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl \< 50 mL/min) will be excluded
    • * Active malignancies
    • * Diabetes
    • * Myasthenia gravis
    • * Immunodeficiency
    • * Autoimmune disease
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 October 2022
  • First Submitted that Met QC Criteria 13 October 2022
  • First Posted 18 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 August 2023
  • Last Update Posted 14 August 2023
  • Last Verified August 2023
I'm interested ...!!