Gamma Globulin Observations and Outcomes Database for Spe... | NCT01774331

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor Decision

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

Jan 18, 2013

First Submission Date that Met QC Criteria

Jan 22, 2013

First Posted Date

Jan 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary:

• Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using infusion nurse measured physical, quality of life (QOL), respiratory, and disability assessments.

Secondary:

Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes.
Change in IVIg dose and timing effects measured outcomes.
Change in patient status is reflected in measured outcomes.
Assess the value to physicians from infusion nurse collected outcomes data.
Identify types of patients by response to IVIg therapy (i.e. natural or poor responders).
Change in response rate to IVIg therapy by disease state and demographics.

Detailed Description

This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting 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, and standard-of-care outcome measures recorded during normal home infusion visits. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Label	Type	Description	Intervention Names
Immunoglobulin Therapy		Immunoglobulin Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data.		5 Years

Secondary Outcomes

Measure	Description	Time Frame
Physician feedback will demonstrate that having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease.		5 Years

Other Outcomes

Measure	Description	Time Frame
Demonstration of response rate for those receiving IVIg.		5 Years
Exhibit differences in response rate of IVIg therapy across disease states and demographics.		5 Years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
Have been on or is between doses of IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
Being considered to be prescribed IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
Determined to be clinically 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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 clinically eligible for infusion services by BriovaRx Infusion Servies (Formerly AxelaCare Health Solutions, LLC), in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.

Sampling Method

Probability Sample