Trial Outcomes & Findings for Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human) (NCT NCT03351933)

NCT ID: NCT03351933

Last Updated: 2019-07-30

Results Overview

Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: Day 60
• Results posted on: 2019-07-30

Participant Flow

A total of 146 subjects were screened for the study, and 8 of them were rescreened. The screen failures were mainly due to body mass index out-of-range. A total of 28 subjects were enrolled in the study.

Participant milestones

Measure	Immune Globulin (Human) GamaSTAN The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Baseline characteristics by cohort

Measure	Immune Globulin (Human) GamaSTAN n=28 Participants The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 60

Population: The efficacy analysis was performed using the Evaluable Population.There are 26 subjects in the Evaluable Population.

Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.

Outcome measures

Measure	Immune Globulin (Human) GamaSTAN n=26 Participants The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels	26 Participants

Adverse Events

Immune Globulin (Human) GamaSTAN

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Immune Globulin (Human) GamaSTAN n=28 participants at risk The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
General disorders Injection site pain	71.4% 20/28 • Number of events 52 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Injury, poisoning and procedural complications Vascular access site haemorrhage	7.1% 2/28 • Number of events 3 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Investigations Neutrophil count decreased	7.1% 2/28 • Number of events 2 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Investigations White blood cell count decreased	7.1% 2/28 • Number of events 2 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Nervous system disorders Headache	17.9% 5/28 • Number of events 5 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 2/28 • Number of events 2 • Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.

Additional Information

Rhonda Griffin

Grifols Therapeutics LLC

Phone: 919-316-6693

Email: rhonda.griffin@grifols.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
• Publication restrictions are in place

Restriction type: OTHER