ASIS for GAMMAGARD in Primary Immunodeficiency

NCT02123615 | Unknown Phase 1 DMC

• 2 other identifiers: NCTEB0178051R01EB017805
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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."

Conditions

Primary Immunodeficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency

  12 months

Other Outcomes (1)

• Adverse Reactions of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency

  12 months

Study Arms (20)

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.

Drug: Gadolinium For abdomen; Drug: Gadolinium For lower back

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.

Drug: Gadolinium For abdomen; Drug: Gadolinium For lower back

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

(%) 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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously 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 24

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

Interventions

Gadolinium For abdomen DRUG

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.

Also known as: Gadolinium Magnevist® (gadopentetate dimeglumine)

Gadolinium For abdomen; Gadolinium For lower back

Gadolinium For lower back DRUG

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.

Also known as: Gadolinium Magnevist® (gadopentetate dimeglumine)

Gadolinium For abdomen; Gadolinium For lower back

Efficacy of Gammagard subcutaneously at Week 12 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Efficacy of Gammagard subcutaneously at Week 24 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Efficacy of Gammagard subcutaneously at Week 36 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Efficacy of Gammagard subdermally at Week 36 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Efficacy of Gammagard subdermally at Week 12 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Efficacy of Gammagard subdermally at Week 24 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

(%) with hospitalized infections; Annual rate hospitalized infections; Annual rate of any infections; Annual rate with Antibiotic use; Annual rate with Days out of work; subjects (%) of any infections; subjects (%) with Antibiotic use; subjects (%) with Days out of work

Adverse Reactions of Gammagard subcutaneously at Week 12 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Adverse Reactions of Gammagard subcutaneously at Week 24 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Adverse Reactions of Gammagard subcutaneously at Week 36 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Adverse Reactions of Gammagard subdermally at Week 12 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Adverse Reactions of Gammagard subdermally at Week 24 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Adverse Reactions of Gammagard subdermally at Week 36 DRUG

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

Also known as: Gammagard [Immune Globulin Infusion (Human)]

Adverse Injection Local Reactions; Adverse Reactions Abdominal Pain; Adverse Reactions Asthma; Adverse Reactions Diarrhea; Adverse Reactions Fatigue; Adverse Reactions Fever; Adverse Reactions Headache; Adverse Reactions Nausea; Adverse Reactions Oropharyngeal; Adverse Reactions Vomiting

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.

Sponsors & Collaborators

• ASIS Corporation: lead

Study Sites (1)

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Related Publications (12)

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  PMID: 980495 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 18466176 BACKGROUND

• 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.

  PMID: 17902731 BACKGROUND

• 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.

  PMID: 12869106 BACKGROUND

• 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.

  PMID: 16783465 BACKGROUND

• 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.

  PMID: 16758340 BACKGROUND

• 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.

  PMID: 16580469 BACKGROUND

• 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.

  PMID: 15945566 BACKGROUND

• 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.

  PMID: 19833910 BACKGROUND

Related Links

• Click here for more information about this study ASIS for GAMMAGARD in Primary Immunodeficiency

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Gadolinium; Gadolinium DTPA; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Nguyen, MD

CONTACT

(714)-453-7857; dr.li.nguyen@asis-inc.com

Thanh Phung, MD

CONTACT

714-893-1915; thanhphung@idit-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 25, 2014
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (1)