NCT02465359

Brief Summary

The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

December 12, 2014

Results QC Date

November 4, 2021

Last Update Submit

September 30, 2024

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms

    This outcome measure, referred to as the relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms, is a measure of how many participants experiences CIDP symptoms causing them to withdraw prematurely from the study. This is a count of participant withdrawals compared to the number of participants who completed the study.

    24 weeks

Secondary Outcomes (13)

  • Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening

    24 weeks

  • Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24

    24 weeks

  • Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening

    24 weeks

  • Treatment Satisfaction Questionnaire for Medication (TSQM)

    24 weeks

  • Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24

    24 weeks

  • +8 more secondary outcomes

Study Arms (1)

Immune globulin subcutaneous (Human)

EXPERIMENTAL

lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly

Drug: Immune Globulin Subcutaneous (Human)

Interventions

Immune Globulin Subcutaneous (Human)DRUG

Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study.

Also known as: Hizentra
Immune globulin subcutaneous (Human)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 activities of daily living (ADL) or work,
  • Paresthesia of sufficient severity to require a medication,
  • Sensory impairment,
  • Walking impairment,
  • AND requires IVIG to control symptoms.

You may not qualify if:

  • Thrombocytopenia or other bleeding disorders,
  • Anticoagulation therapy,
  • Severe or anaphylactoid reactions to IVIG,
  • Cancer,
  • Pregnancy,
  • Breast-feeding,
  • Renal insufficiency or failure,
  • Congestive heart failure,
  • Psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Dept of Neurology

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

gamma-GlobulinsHizentra

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Small, open-label trial; lacks immunoglobulin G (IgG)-dependency test; predictors of poor QOL were not substratified during analysis of the primary and secondary endpoints; lack of baseline IVIg observation period.

Results Point of Contact

Title
Tuan H. Vu, MD
Organization
University of South Florida
tvu6@usf.edu
813-974-9413

Study Officials

  • Tuan Vu, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

June 8, 2015

Study Start

September 1, 2014

Primary Completion

March 1, 2018

Study Completion

May 1, 2021

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-09

Locations

US(1)