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ASIS for GAMMAGARD in Primary Immunodeficiency (ASISinPI)

Primary Purpose

Primary Immunodeficiency

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gadolinium For abdomen

Gadolinium For lower back

Efficacy of Gammagard subcutaneously at Week 12

Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 36

Efficacy of Gammagard subdermally at Week 36

Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 24

Efficacy of Gammagard subdermally at Week 36

Adverse Reactions of Gammagard subcutaneously at Week 12

Adverse Reactions of Gammagard subcutaneously at Week 24

Adverse Reactions of Gammagard subcutaneously at Week 36

Adverse Reactions of Gammagard subdermally at Week 12

Adverse Reactions of Gammagard subdermally at Week 24

Adverse Reactions of Gammagard subdermally at Week 36

About this trial

This is an interventional treatment trial for Primary Immunodeficiency focused on measuring Primary Immunodeficiency, Subdermal bloodless space, Subdermal injection, Subcutaneous injection, Injectable electromyography needle, Electrical stimulation, MRI with Gadolinium

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria in general and for Gadolinium:
- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
- Must be outpatient, male or female, of any race, between 18 and 65 years of age.
- Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
- Must be in good general health as determined by investigator.
- If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception
Inclusion Criteria for Primary Immunodeficiency in particular:
- Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.

Exclusion Criteria:

Exclusion Criteria for Primary Immunodeficiency in particular:
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.

Sites / Locations

Automatic Subdermal Injector System, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm Type

Experimental

Arm Label

Gadolinium For abdomen

Gadolinium For lower back

subjects (%) of any infections

Annual rate of any infections

subjects (%) with Antibiotic use

Annual rate with Antibiotic use

subjects (%) with Days out of work

Annual rate with Days out of work

(%) with hospitalized infections

Annual rate hospitalized infections

Adverse Injection Local Reactions

Adverse Reactions Headache

Adverse Reactions Fever

Adverse Reactions Nausea

Adverse Reactions Vomiting

Adverse Reactions Fatigue

Adverse Reactions Diarrhea

Adverse Reactions Asthma

Adverse Reactions Oropharyngeal

Adverse Reactions Abdominal Pain

Arm Description

Gadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score.

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Outcomes

Primary Outcome Measures

Relative Prolongation Ability Score for Gadolinium subdermally injected

Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.

Secondary Outcome Measures

Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency

The therapeutic efficacy of GAMMAGARD, in terms of reduction of Validated Acute Serious Bacterial Infections will be compared, eg. subjects (%) and Annual rate of any infections, subjects (%) and Annual rate of Antibiotic use, subjects (%) and Annual rate with Days out of work, subjects (%) and Annual rate of hospitalized infections, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.

Full Information

NCT ID

NCT02123615

First Posted

April 11, 2014

Last Updated

June 22, 2015

Sponsor

ASIS Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02123615

Brief Title

ASIS for GAMMAGARD in Primary Immunodeficiency

Acronym

ASISinPI

Official Title

ASIS for GAMMAGARD in Primary Immunodeficiency

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ASIS Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."

Detailed Description

Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease. 30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2. Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G. However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Immunodeficiency

Keywords

Primary Immunodeficiency, Subdermal bloodless space, Subdermal injection, Subcutaneous injection, Injectable electromyography needle, Electrical stimulation, MRI with Gadolinium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gadolinium For abdomen

Arm Type

Experimental

Arm Description

Arm Title

Gadolinium For lower back

Arm Type

Experimental

Arm Description

Arm Title

subjects (%) of any infections

Arm Type

Experimental

Arm Description

Arm Title

Annual rate of any infections

Arm Type

Experimental

Arm Description

Arm Title

subjects (%) with Antibiotic use

Arm Type

Experimental

Arm Description

Arm Title

Annual rate with Antibiotic use

Arm Type

Experimental

Arm Description

Arm Title

subjects (%) with Days out of work

Arm Type

Experimental

Arm Description

Arm Title

Annual rate with Days out of work

Arm Type

Experimental

Arm Description

Arm Title

(%) with hospitalized infections

Arm Type

Experimental

Arm Description

Arm Title

Annual rate hospitalized infections

Arm Type

Experimental

Arm Description

Arm Title

Adverse Injection Local Reactions

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Headache

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Fever

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Nausea

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Vomiting

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Fatigue

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Diarrhea

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Asthma

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Oropharyngeal

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions Abdominal Pain

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gadolinium For abdomen

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type

Drug

Intervention Name(s)

Gadolinium For abdomen

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type

Drug

Intervention Name(s)

Gadolinium For abdomen

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Intervention Type

Drug

Intervention Name(s)

Gadolinium For lower back

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.

Intervention Type

Drug

Intervention Name(s)

Gadolinium For lower back

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.

Intervention Type

Drug

Intervention Name(s)

Gadolinium For lower back

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Efficacy of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subcutaneously at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subcutaneously at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subcutaneously at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subdermally at Week 12

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subdermally at Week 24

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Gammagard subdermally at Week 36

Other Intervention Name(s)

Gammagard [Immune Globulin Infusion (Human)]

Intervention Description

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Primary Outcome Measure Information:

Title

Relative Prolongation Ability Score for Gadolinium subdermally injected

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Adverse Reactions of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency

Description

Adverse Reactions of GAMMAGARD, in numbers of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain will be compared, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria in general and for Gadolinium: Main Criteria for Inclusion: Eligible Ages: 12 Years to 65 Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Must be outpatient, male or female, of any race, between 18 and 65 years of age. Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent. Must be in good general health as determined by investigator. If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception Inclusion Criteria for Primary Immunodeficiency in particular: Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2. Exclusion Criteria: Exclusion Criteria for Primary Immunodeficiency in particular: Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Nguyen, MD

Phone

(714)-453-7857

dr.li.nguyen@asis-inc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Thanh Phung, MD

Phone

714-893-1915

thanhphung@idit-inc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Nguyen, MD

Organizational Affiliation

AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thanh Phung, MD

Organizational Affiliation

AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hanh Nguyen, MD

Organizational Affiliation

AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Automatic Subdermal Injector System, Inc

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Nguyen, MD

Phone

714-453-7857

dr.li.nguyen@asis-inc.com

First Name & Middle Initial & Last Name & Degree

Thanh Phung, MD

Phone

(714)-893-1915

thanhphung@idit-inc.com

First Name & Middle Initial & Last Name & Degree

Li Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Thanh Phung, MD

First Name & Middle Initial & Last Name & Degree

Hanh Nguyen, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

980495

Citation

Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.

Results Reference

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Citation

Magnevist (gadopentetate dimeglumine) Injection Product Information: http://pharma.bayer.com/scripts/pages/en/products/diagnostic_imaging/index.php

Results Reference

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Citation

Botox (onabotulinumtoxinA) Product Information: http://www.botoxcosmetic.com/botox_physician_info/Clinical_Information.aspx http://www.clinicaltrials.gov/ct2/show/NCT01313767?term=Botox+pi&rank=1

Results Reference

background

Citation

GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID): http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5

Results Reference

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PubMed Identifier

18466176

Citation

Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2.

Results Reference

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PubMed Identifier

17902731

Citation

Mignogna MD, Fortuna G, Ruoppo E, Adamo D, Leuci S, Fedele S. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat? Am J Clin Dermatol. 2007;8(5):291-9. doi: 10.2165/00128071-200708050-00004.

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PubMed Identifier

12869106

Citation

Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion. 2003 Aug;43(8):1023-8. doi: 10.1046/j.1537-2995.2003.00496.x.

Results Reference

background

PubMed Identifier

16783465

Citation

Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M; Subcutaneous IgG Study Group. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006 May;26(3):265-73. doi: 10.1007/s10875-006-9021-7.

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PubMed Identifier

16758340

Citation

Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.

Results Reference

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PubMed Identifier

16580469

Citation

Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, Buckley R, Chinen J, El-Gamal Y, Mazer BD, Nelson RP Jr, Patel DD, Secord E, Sorensen RU, Wasserman RL, Cunningham-Rundles C; Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006 Apr;117(4 Suppl):S525-53. doi: 10.1016/j.jaci.2006.01.015. Erratum In: J Allergy Clin Immunol. 2006 Jun;117(6):1483. Dosage error in article text.

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PubMed Identifier

15945566

Citation

Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available. Erratum In: Ann Allergy Asthma Immunol. 2006 Mar;96(3):504.

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PubMed Identifier

19833910

Citation

Kahwaji J, Barker E, Pepkowitz S, Klapper E, Villicana R, Peng A, Chang R, Jordan SC, Vo AA. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol. 2009 Dec;4(12):1993-7. doi: 10.2215/CJN.04540709. Epub 2009 Oct 15.

Results Reference

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ASIS for GAMMAGARD in Primary Immunodeficiency

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