Primary Immune Deficiency DisorderNCT01883921
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
An observational study of Primary Immune Deficiency Disorder, run by BriovaRx Infusion Services at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Primary Immune Deficiency Disorder
- What is being tested?
- Immunoglobulin Therapy
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read more
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.
Read the 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.
- Conditions
- Primary Immune Deficiency Disorder
- Being tested
- Immunoglobulin Therapy
- Keywords
- Primary Immunodeficiency, Immunodeficiencies, Primary Immunodeficiency Diseases, PIDD, CVID, PI, Common Variable Immunodeficiency, Hypogammaglobulinemia, Acquired Hypogammaglobulinemia, Immunology, Autoimmune Deficiency, Intravenous Immunoglobulin, Subcutaneous Immunoglobulin, IVIg, SCIg, Immune Globulin, Outcomes Research, Immunodeficiency
- Medical subject headings
- Primary Immunodeficiency Diseases, Immunologic Deficiency Syndromes, Common Variable Immunodeficiency, Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Immunoglobulin Therapy | Not described Receives: Other: Immunoglobulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients.
Measured: Up to 5 Years
Secondary outcomes (4)
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.
Measured: Up to 5 Years
Response rate for those receiving IVIg/SCIg therapies.
Measured: Up to 5 Years
Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics
Measured: Up to 5 Years
Measure variables within patients who receive IVIg/SCIg therapies
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BriovaRx Infusion Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883921
- Sponsor's protocol ID
- BIS1-13-002
- Status last verified
- Aug 2019
- First submitted
- 19 Jun 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01883921
- Acronym / sponsor ID
- BIS1-13-002
- Conditions
- Primary Immune Deficiency Disorder
- Keywords
- Primary Immunodeficiency, Immunodeficiencies, Primary Immunodeficiency Diseases, PIDD, CVID, PI, Common Variable Immunodeficiency, Hypogammaglobulinemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- BriovaRx Infusion ServicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoglobulin Therapy | – | Other: Immunoglobulin Therapy |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin Therapy | Other | Immunoglobulin Therapy |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency Disorder, run by BriovaRx Infusion Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.