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Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883921
Recruitment Status : Terminated (Sponsor Decision)
First Posted : June 21, 2013
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services

Tracking Information
First Submitted Date June 19, 2013
First Posted Date June 21, 2013
Last Update Posted Date August 7, 2019
Study Start Date June 2013
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2013)
Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients. [ Time Frame: Up to 5 Years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2013)
  • Physician feedback will demonstrate if having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease. [ Time Frame: Up to 5 Years ]
  • Response rate for those receiving IVIg/SCIg therapies. [ Time Frame: Up to 5 Years ]
  • Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics [ Time Frame: Up to 5 Years ]
  • Measure variables within patients who receive IVIg/SCIg therapies [ Time Frame: Up to 5 Years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Official Title Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data in Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Brief Summary

Primary:

  • Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and disability assessments in patients with Primary Immunodeficiency Disease (PIDD).

Secondary:

  • Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured outcomes.
  • Change in IVIg/SCIg dose timing effects measured outcomes.
  • Change in patient status is reflected in measured outcomes.
  • Assess the value to physicians from collected outcomes data.
  • Identify types of patients by response to IVIg/SCIg therapies (well maintained, problematic, etc.).
  • Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state, co-morbidities, and demographics.
Detailed Description This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting PIDD adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, standard-of-care outcome measures, and Ig administration information recorded during normal home infusion visits. There will also be standard-of-care questions captured within some outcome measures recorded during normal home infusion visits that may be at a frequency and/or combination which may not be considered routine clinical care by some physicians who treat for this medical condition. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any patient who is aged 7 years or greater at time of enrollment; who is on Ig therapy, have been on or is between doses of Ig therapy, or is being considered to be prescribed Ig therapy; provides informed consent for participation; and who has been determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC), in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.
Condition Primary Immune Deficiency Disorder
Intervention Other: Immunoglobulin Therapy
Study Groups/Cohorts Immunoglobulin Therapy
Intervention: Other: Immunoglobulin Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: June 20, 2013)
1500
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of any form of Primary Immunodeficiency Disease
  • Age at enrollment ≥ 7
  • Sign informed consent/assented to participation
  • Ability to read and write English
  • Understanding of study procedures and ability to comply with study procedures for the entire length of the study
  • Receiving Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
  • Have been on or is between doses of Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
  • Being considered to be prescribed Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
  • Determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician

Exclusion Criteria:

  • Children (age ≤ 6 years)
  • Prisoners, and other wards of the state
  • Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by the study participant's caregiver
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01883921
Other Study ID Numbers BIS1-13-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services
Study Sponsor BriovaRx Infusion Services
Collaborators Not Provided
Investigators Not Provided
PRS Account BriovaRx Infusion Services
Verification Date August 2019