ASISinPI: ASIS for GAMMAGARD in Primary Immunodeficiency

Sponsor

ASIS Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02123615

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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."

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency	Drug: Gadolinium For abdomen Drug: Gadolinium For abdomen Drug: Gadolinium For abdomen Drug: Gadolinium For lower back Drug: Gadolinium For lower back Drug: Gadolinium For lower back Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Adverse Reactions of Gammagard subcutaneously at Week 12 Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Drug: Adverse Reactions of Gammagard subdermally at Week 12 Drug: Adverse Reactions of Gammagard subdermally at Week 24 Drug: Adverse Reactions of Gammagard subdermally at Week 36	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

ASIS for GAMMAGARD in Primary Immunodeficiency

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Relative Prolongation Ability Score for Gadolinium subdermally injected [6 months]
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 [12 months]
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.

Other Outcome Measures

Adverse Reactions of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Automatic Subdermal Injector System, Inc	Westminster	California	United States	92683

Sponsors and Collaborators

ASIS Corporation

Investigators

Principal Investigator: Li Nguyen, MD, AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Principal Investigator: Thanh Phung, MD, AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
Principal Investigator: Hanh Nguyen, MD, AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC