Clinical Trials/NCT02123615

NCT02123615UnknownPhase 1

ASIS for GAMMAGARD in Primary Immunodeficiency

ASIS Corporation1 site in 1 country60 target enrollmentStarted: January 2016Last updated: June 24, 2015

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Sponsor: ASIS Corporation
Enrollment: 60
Locations: 1
Primary Endpoint: Relative Prolongation Ability Score for Gadolinium subdermally injected

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages: 21 Years to 65 Years (Adult, Older Adult)
Sex: 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.

Arms & Interventions

Gadolinium For abdomen

Experimental

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.

Intervention: Gadolinium For abdomen (Drug)

Gadolinium For abdomen

Experimental

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.

Intervention: Gadolinium For lower back (Drug)

Gadolinium For lower back

Experimental

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.

Intervention: Gadolinium For abdomen (Drug)

Gadolinium For lower back

Experimental

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.

Intervention: Gadolinium For lower back (Drug)

subjects (%) of any infections

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

subjects (%) of any infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

subjects (%) of any infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

subjects (%) of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

subjects (%) of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

subjects (%) of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

Annual rate of any infections

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

Annual rate of any infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

Annual rate of any infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

Annual rate of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

Annual rate of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

Annual rate of any infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

subjects (%) with Antibiotic use

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

subjects (%) with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

subjects (%) with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

subjects (%) with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

subjects (%) with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

subjects (%) with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

Annual rate with Antibiotic use

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

Annual rate with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

Annual rate with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

Annual rate with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

Annual rate with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

Annual rate with Antibiotic use

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

subjects (%) with Days out of work

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

subjects (%) with Days out of work

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

subjects (%) with Days out of work

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

subjects (%) with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

subjects (%) with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

subjects (%) with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

Annual rate with Days out of work

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

Annual rate with Days out of work

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

Annual rate with Days out of work

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

Annual rate with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

Annual rate with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

Annual rate with Days out of work

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

(%) with hospitalized infections

Experimental

(%) 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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

(%) with hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

(%) with hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

(%) with hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

(%) with hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

(%) with hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

Annual rate hospitalized infections

Experimental

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.

Intervention: Efficacy of Gammagard subcutaneously at Week 12 (Drug)

Annual rate hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 24 (Drug)

Annual rate hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subcutaneously at Week 36 (Drug)

Annual rate hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 36 (Drug)

Annual rate hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 12 (Drug)

Annual rate hospitalized infections

Experimental

Intervention: Efficacy of Gammagard subdermally at Week 24 (Drug)

Adverse Injection Local Reactions

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Injection Local Reactions

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Injection Local Reactions

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Injection Local Reactions

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Injection Local Reactions

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Injection Local Reactions

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Headache

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Headache

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Headache

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Headache

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Headache

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Headache

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Fever

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Fever

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Fever

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Fever

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Fever

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Fever

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Nausea

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Nausea

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Nausea

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Nausea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Nausea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Nausea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Vomiting

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Vomiting

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Vomiting

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Vomiting

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Vomiting

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Vomiting

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Fatigue

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Fatigue

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Fatigue

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Fatigue

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Fatigue

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Fatigue

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Diarrhea

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Diarrhea

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Diarrhea

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Diarrhea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Diarrhea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Diarrhea

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Asthma

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Asthma

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Asthma

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Asthma

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Asthma

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Asthma

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Oropharyngeal

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Oropharyngeal

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Oropharyngeal

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Oropharyngeal

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Oropharyngeal

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Oropharyngeal

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Adverse Reactions Abdominal Pain

Experimental

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.

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 12 (Drug)

Adverse Reactions Abdominal Pain

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 24 (Drug)

Adverse Reactions Abdominal Pain

Experimental

Intervention: Adverse Reactions of Gammagard subcutaneously at Week 36 (Drug)

Adverse Reactions Abdominal Pain

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 12 (Drug)

Adverse Reactions Abdominal Pain

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 24 (Drug)

Adverse Reactions Abdominal Pain

Experimental

Intervention: Adverse Reactions of Gammagard subdermally at Week 36 (Drug)

Outcomes

Primary Outcomes

Relative Prolongation Ability Score for Gadolinium subdermally injected

Time Frame: 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 Outcomes

Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency(12 months)

Investigators

Sponsor

ASIS Corporation

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Unknown

Phase 1

ASIS for Enbrel in Plaque PsoriasisPlaque Psoriasis.

NCT02112097ASIS Corporation60

Completed

Phase 1

To Assess the Patients' Ability to Self-Administer FasinumabOsteoarthritis, HipOsteoarthritis, Knee

NCT03491904Regeneron Pharmaceuticals100

Completed

Not Applicable

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal ChallengesType 1 Diabetes Mellitus

NCT03848767Eli Lilly and Company10

Completed

Not Applicable

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)Type 1 Diabetes Mellitus

NCT03743285Eli Lilly and Company10

Completed

Phase 1

A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)Type1 Diabetes Mellitus

NCT03367390Eli Lilly and Company30