Primary Immunodeficiency Disease (PIDD)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
An observational study of Primary Immunodeficiency Disease (PIDD), run by BriovaRx Infusion Services at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Primary Immunodeficiency Disease (PIDD)
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2014to 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and Females between 15-85 years of age with any form of PIDD who are considered 5% IVIg treatment naïve and whose physician has decided to prescribe Gammaplex® IVIg therapy.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlanta ENT
Atlanta, Georgia, 30342
IMMUNEOe International Research Centers
Centennial, Colorado, 80122
AxelaCare Health Solutions, LLC
Lenexa, Kansas, 66219
Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare)
Newport Beach, California, 92663
About this study
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.
- Conditions
- Primary Immunodeficiency Disease (PIDD)
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gammaplex® IVIg | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (8)
Evaluate the profile physician usage (dose and timing) with Gammaplex®.
Measured: 1 year
Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.
Measured: 1 year
Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.
Measured: 1 year
Demonstration of response rate for those receiving IVIg therapies.
Measured: 1 year
Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.
Measured: 1 year
Demonstration of measured variables within patients who receive IVIg therapies.
Measured: 1 year
Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.
Measured: 1 year
Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Disease (PIDD)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BriovaRx Infusion Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio Products Laboratory
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176239
- Sponsor's protocol ID
- AHS1-13-003
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2014
- 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
- 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
- ClinicalTrials.gov ID
- NCT02176239
- Acronym / sponsor ID
- AHS1-13-003
- Conditions
- Primary Immunodeficiency Disease (PIDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BriovaRx Infusion ServicesIndustry (pharma, biotech, devices)
- Collaborators
- Bio Products Laboratory
- Study start
- Jun 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 27 Jun 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gammaplex® IVIg | – | – |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and Females between 15-85 years of age with any form of PIDD who are considered 5% IVIg treatment naïve and whose physician has decided to prescribe Gammaplex® IVIg therapy.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Evaluate the profile physician usage (dose and timing) with Gammaplex®.
Time frame: 1 year
Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.
Time frame: 1 year
Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.
Time frame: 1 year
Demonstration of response rate for those receiving IVIg therapies.
Time frame: 1 year
Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.
Time frame: 1 year
Demonstration of measured variables within patients who receive IVIg therapies.
Time frame: 1 year
Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.
Time frame: 1 year
Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Disease (PIDD), run by BriovaRx Infusion Services at 4 sites 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 4 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: finished, 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 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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). 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; AzTrials last refreshed its copy on 8 Nov 2026.