ASIS for GAMMAGARD in Primary Immunodeficiency

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."

Conditions

• Primary Immunodeficiency

Interventions

DRUG

Gadolinium For abdomen

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.

DRUG

Gadolinium For abdomen

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.

DRUG

Gadolinium For abdomen

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

DRUG

Gadolinium For lower back

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.

DRUG

Gadolinium For lower back

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.

DRUG

Gadolinium For lower back

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 12

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 24

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

DRUG

Efficacy of Gammagard subcutaneously at Week 36

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

DRUG

Efficacy of Gammagard subcutaneously at Week 36

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

DRUG

Efficacy of Gammagard subcutaneously at Week 36

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

DRUG

Efficacy of Gammagard subcutaneously at Week 36

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

DRUG

Efficacy of Gammagard subcutaneously at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 12

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 24

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Efficacy of Gammagard subdermally at Week 36

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

DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12

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

DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24

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

DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36

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

DRUG

Adverse Reactions of Gammagard subdermally at Week 12

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

DRUG

Adverse Reactions of Gammagard subdermally at Week 24

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

DRUG

Adverse Reactions of Gammagard subdermally at Week 36

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

Sponsors & Collaborators

• ASIS Corporation

  lead INDUSTRY

Principal Investigators

• Li Nguyen, MD · AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

• Thanh Phung, MD · AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

• Hanh Nguyen, MD · AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States

Study Locations