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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone: 714-453-7857
Email: dr.li.nguyen@asis-inc.com
Affiliation: 
Name:     Li Nguyen, MD
Address: 
Telephone: (714)-453-7857
Email: dr.li.nguyen@asis-inc.com
Affiliation: 
Name:     Li Nguyen, MD
Address: 
Telephone:
Email:
Affiliation:  AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Name:     Thanh Phung, MD
Address: 
Telephone:
Email:
Affiliation:  AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
Name:     Hanh Nguyen, MD
Address: 
Telephone:
Email:
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: 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
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 12
Drug: Efficacy of Gammagard subdermally at Week 24
Drug: Efficacy of Gammagard subdermally at Week 36
Drug: Gadolinium For abdomen
Drug: Gadolinium For lower back
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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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