IVIG vs SCIG in CIDP

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05584631
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • CIDP
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Immunoglobulin Deficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravenous immune globulin G — DRUG
    Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.
  • Subcutaneous immune globulin G — DRUG
    Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.

Study Details

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.

Key Dates

Start date
Sep 11, 2022
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Intravenous immune globulin G
    Subjects will receive there current intravenous immune globulin dose.
  • Experimental: Subcutaneous immune globulin G
    The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).

Primary Outcome Measure

Assessment of drug half-life [ Time Frame: Through study completion, an average of 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers, The State University of New Jersey Clinical Research CenterNew BrunswickNew Jersey08901
Luigi Brunetti, PhD
[email protected]
9085952645

Find similar trials in New Brunswick, NJ

By research site
Rutgers, The State University of New Jersey Clinical Research Center· New Brunswick, NJ

Related Studies