ASIS for GAMMAGARD in Primary Immunodeficiency

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

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.

Trial Locations (1)

92683

Automatic Subdermal Injector System, Inc, Westminster

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ASIS Corporation

INDUSTRY