Skip to main content
OpenTrials
Completed

NCT Number: NCT02176239

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Immunodeficiency Disease (PIDD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare), Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.

    Time frame: 1 year

Secondary outcomes

  1. Evaluate the profile physician usage (dose and timing) with Gammaplex®.

    Time frame: 1 year

  2. Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.

    Time frame: 1 year

  3. Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.

    Time frame: 1 year

  4. Demonstration of response rate for those receiving IVIg therapies.

    Time frame: 1 year

  5. Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.

    Time frame: 1 year

  6. Demonstration of measured variables within patients who receive IVIg therapies.

    Time frame: 1 year

  7. Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.

    Time frame: 1 year

  8. Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

BriovaRx Infusion Services

Industry

Collaborators

  • Bio Products Laboratory (BPL)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2014
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.