ASIS for GAMMAGARD in Primary Immunodeficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02123615
• Date of registration: 11/04/2014
• Prospective Registration: Yes
• Primary sponsor: ASIS Corporation
• Public title: ASIS for GAMMAGARD in Primary Immunodeficiency ASISinPI
• Scientific title: ASIS for GAMMAGARD in Primary Immunodeficiency
• Date of first enrolment: January 2016
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02123615
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Li Nguyen, MD

• Name: Thanh Phung, MD
• Affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

• Name: Hanh Nguyen, MD
• Affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC

• Name: Li Nguyen, MD

• Name: Li Nguyen, MD
• Affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

Key inclusion & exclusion criteria

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.



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency

Intervention(s)

Drug: Gadolinium For abdomen

Drug: Efficacy of Gammagard subdermally at Week 24

Drug: Adverse Reactions of Gammagard subcutaneously at Week 36

Drug: Adverse Reactions of Gammagard subdermally at Week 36

Drug: Efficacy of Gammagard subcutaneously at Week 12

Drug: Efficacy of Gammagard subdermally at Week 12

Drug: Gadolinium For lower back

Drug: Adverse Reactions of Gammagard subdermally at Week 12

Drug: Adverse Reactions of Gammagard subcutaneously at Week 12

Drug: Efficacy of Gammagard subcutaneously at Week 24

Drug: Adverse Reactions of Gammagard subcutaneously at Week 24

Drug: Efficacy of Gammagard subdermally at Week 36

Drug: Adverse Reactions of Gammagard subdermally at Week 24

Drug: Efficacy of Gammagard subcutaneously at Week 36

Primary Outcome(s)

Relative Prolongation Ability Score for Gadolinium subdermally injected [Time Frame: 6 months]

Secondary Outcome(s)

Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency [Time Frame: 12 months]

Secondary ID(s)

1R01EB017805

NCTEB017805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors