Overview

Subcutaneous Immunoglobulin for CIDP

Status:
Completed
Trial end date:
2021-05-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators are using self administered subcutaneous IG in patients with CIDP who require IVIG. Safety, efficacy, and patient satisfaction will be examined.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of South Florida
Collaborator:
CSL Behring
Treatments:
Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Criteria
Inclusion Criteria:

To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or
more of the following):

- Weakness in any limb,

- Motor fatigue significant to interfere with ADL or work,

- Paresthesia of sufficient severity to require a medication,

- Sensory impairment,

- Walking impairment,

AND requires IVIG to control symptoms.

Exclusion Criteria:

1. Thrombocytopenia or other bleeding disorders,

2. Anticoagulation therapy,

3. Severe or anaphylactoid reactions to IVIG,

4. Cancer,

5. Pregnancy,

6. Breast-feeding,

7. Renal insufficiency or failure,

8. Congestive heart failure,

9. Psychiatric illness.