Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)

NCT01774331

Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

TERMINATED

Evaluation of the Aurora Xi New Nomogram Software 2.0

NCT06122935

Apheresis Related Hypotension

COMPLETED NA

A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

NCT02246855

Healthy

COMPLETED PHASE1

Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro

NCT06329843

Neonatal Jaundice

RECRUITING

Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

NCT07272161

Nuclear Medicine

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Immunodeficiency Disease (PIDD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gammaplex® IVIg

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of any form of Primary Immunodeficiency Disease
* Males and Females
* ≥ 15 and ≤ 85 years of age
* 5% treatment Naïve IVIg for the treatment of PIDD
* Ability to have Gammaplex® IVIg prescribed under the discretion of the patient's treating physician in accordance with standard treatment practices for the entire duration of the study
* Ability and willingness to provide informed consent and comply with study requirements and procedures
* Ability to read and write English
* Understanding of study procedures and ability to comply with study procedures for the entire length of the study
* Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration with the subject's prescribing physician and insurance provider

Exclusion Criteria

* The presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial.
* Prisoners, and other wards of the state
* Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by either the home infusion nurse and/or Caregiver.
* Receiving Subcutaneous Immunoglobulin (SCIg) Therapy during study participation.

Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No