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Immunomodulator

IVIG vs SCIG for CIDP

Phase 1
Waitlist Available
Led By Luigi Brunetti, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how body weight affects the effectiveness of IgG when given through IV or injection.

Who is the study for?
This trial is for adults over 18 with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They must meet specific diagnostic criteria and have a dosage conversion rate that fits the study's range. People with active cancer, immune or autoimmune diseases, diabetes, myasthenia gravis, or significant liver or kidney issues cannot participate.
What is being tested?
The study compares two ways of giving immunoglobulin G (IgG) to CIDP patients: through the veins (IVIG) and under the skin (SCIG). It aims to see how body composition affects these methods in people with different body weights.
What are the potential side effects?
Possible side effects include reactions at the injection site like redness and swelling, headaches, fever, nausea, fatigue. Rarely there can be more serious reactions such as blood clots or kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of drug half-life
Immunoglobulins
Immunoglobulins
Secondary study objectives
Fatigue
Assessment of grip strength
Assessment of muscle function
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subcutaneous immune globulin GExperimental Treatment1 Intervention
The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).
Group II: Intravenous immune globulin GExperimental Treatment1 Intervention
Subjects will receive there current intravenous immune globulin dose.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,931 Total Patients Enrolled
Luigi Brunetti, PhDPrincipal InvestigatorRutgers, The State University of New Jersey
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Intravenous immune globulin G (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05584631 — Phase 1
Primary Immunodeficiency Research Study Groups: Intravenous immune globulin G, Subcutaneous immune globulin G
Primary Immunodeficiency Clinical Trial 2023: Intravenous immune globulin G Highlights & Side Effects. Trial Name: NCT05584631 — Phase 1
Intravenous immune globulin G (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584631 — Phase 1
Primary Immunodeficiency Patient Testimony for trial: Trial Name: NCT05584631 — Phase 1
~6 spots leftby Dec 2025
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