A Study to Evaluate the Pharmacokinetics, Safety, and Tol... | NCT04561115

NCT04561115

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gamunex-C	Active Comparator	Participants received Gamunex-C by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. Gamunex-C was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of Gamunex-C treatment included the Gamunex-C PK Phase (up to 4 weeks) plus the additional Gamunex-C Run-in Phase (up to 4.5 months) for participants not receiving Gamunex-C or not on a stable dose of Gamunex-C upon entering the trial. The approximate maximum duration was up to 6 months.	Biological: Gamunex-C
IVIG-PEG	Experimental	Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.	Biological: IVIG-PEG

Name	Type	Description	Arm Group Labels	Other Names
Gamunex-C	Biological	Intravenous infusion.	Gamunex-C	IVIG-C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin G (IgG)	AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.	Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours and 4, 7, 14 and 21 days (up to 3 weeks), and 28 days (up to 4 weeks - only for subjects on a 4-week dosing schedule) post-infusion
Cmax: Maximum Concentration in a Dosing Interval for Total IgG		Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours, and 4, 7, 14, 21 and 28 days post-infusion (up to 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Rate of Serious Bacterial Infections (SBIs)	The rate of SBI events per participant per year during treatment was calculated as the total number of SBI events divided by the total duration of exposure in years across all participants. The 2-sided 98% confidence interval (CI) was determined from a generalized linear model for Poisson regression for the log-transformed number of events with log-transformed duration of exposure in years as an offset variable.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 18 and 75 years of age (inclusive) at Screening
Documented and confirmed pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IV IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M [IgM] immunodeficiency syndrome).
IgG trough level ≥500 milligrams per deciliter (mg/dL) at screening visit. Note: Patients entering Group 1 must additionally have trough levels ≥500 mg/dL documented within the previous year. For patients entering Group 2, if Screening trough levels are not ≥500 mg/dL, the subject will be a Screen Failure, but may be rescreened following dose adjustment of their original IV IgG replacement therapy regimen and recording an IgG trough level ≥500 mg/dL
Has not had an SBI within the last 6 months prior to screening or during the screening.
Medical records are available to document diagnosis, previous infections, and treatment.
Willing to comply with all aspects of the study protocol, including blood sampling, for the duration of the study.
Signed and dated a written informed consent form (ICF) confirming his or her willingness to participate in study GC1902.

Exclusion Criteria:

Has an acquired medical condition that is known to cause secondary immune deficiency such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000per microliters (1000/μL) [1.0 x 10^9/L]), or human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS).
Has known selective Immunoglobulin A (IgA) deficiency (with or without antibodies to IgA). (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of primary humoral immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).
Has isolated IgG subclass deficiency or an isolated specific antibody deficiency disorder, or transient hypogammaglobulinemia of infancy
The subject has had a known serious adverse reaction to immunoglobulin or any severe anaphylactic reaction to blood or any blood-derived product.
Has a history of thrombotic complications following IVIG therapy.
Has a history of or current diagnosis of deep venous thrombosis (DVT) or thromboembolism (e.g., myocardial infarction, cerebrovascular accident or transient ischemic attack); history refers to an incident in the year prior to the Screening Visit or 2 episodes over lifetime or has thrombosis risk factors (e.g., prolonged immobilization, use of estrogens, indwelling central vascular catheters).
Has a known hyperviscosity syndrome or hypercoagulable states.
Has liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 2.5 times the upper limit of normal (ULN) at the screening visit as defined by the testing laboratory.
Has pre-existing renal impairment (defined by serum creatinine greater than 1.5 times the ULN or blood urea nitrogen [BUN] greater than 2.5 times the ULN, or any subject who is on dialysis) at the screening visit or any history of acute renal injury.
Has clinically significant history of drug or alcohol abuse or dependence in the opinion of the Investigator (must be within the past 12 months and noted in the subject's medical records or documented at screening).
Clinical evidence of any significant acute or chronic medical condition (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state) that, in the opinion of the Investigator, may interfere with the conduct of the study or may place the subject at undue medical risk.
Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening (human chorionic gonadotropin [HCG]-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (eg, oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study. Note: True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
Receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids defined as daily dose >1 mg of prednisone equivalent/kg/day for >30 days. Note: Intermittent courses not exceeding >1mg of prednisone equivalent/kg/day for >30 days would not exclude the subject. Inhaled or topical corticosteroids are allowed.
Has uncontrolled arterial hypertension (systolic blood pressure [SBP] >160 mm Hg and/or diastolic blood pressure [DBP] >100 mm Hg)
Has hemoglobin <11 g/dL at the Screening Visit
Unable or unwilling to provide a storage serum sample at the Screening Visit. Note: A pre-treatment serum sample to be stored at -94°F (-70ºC) for possible future testing is required.
Received any live virus vaccine within 5 months prior to the Screening Visit and not willing to postpone receiving any live virus vaccines until 6 months after completing study treatment
Has a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has participated in another clinical trial within 30 days prior to Screening or has received any investigational product, with the exception of other IgG products, within the previous 3 months prior to the Screening Visit

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Allergy & Asthma Center		Birmingham	Alabama	35209	United States
Allergy Associates of the Palm Beaches PA

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 1, 2021	Jun 2, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

FG00022 subjectsParticipants not on stable GC treatment entered the GC Run-in Phase to receive GC treatment to achieve an approximate steady-state condition prior to entering the GC PK Phase.
FG0010 subjects

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or Gamunex-C).

Arm/Group Information

ID	Title	Description
BG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.

Units	Counts
Participants	BG00033

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.5± 14.02

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016
Male	BG00017

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001
Not Hispanic or Latino	BG00032

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin G (IgG)

AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.

The PK population consisted of all participants who received study drug and had sufficient and valid total IgG concentration versus time data for either the IVIG-PEG PK Phase or GC PK Phase to allow calculation of AUC0-τ. Overall number analyzed are the number of participants with data available for analysis.

Posted

Mean

Standard Deviation

hour*milligrams per decilitres (h*mg/dL)

Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours and 4, 7, 14 and 21 days (up to 3 weeks), and 28 days (up to 4 weeks - only for subjects on a 4-week dosing schedule) post-infusion

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
OG001	IVIG-PEG	Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.

Units	Counts
Participants	OG00029 OG00131

Title

Denominators

Categories

Title	Measurements
	OG000232088.8± 32848.46 OG001219149.9± 36894.29

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Geometric Least Square Mean Ratio	0.948			2-Sided	90	0.926	0.972					Equivalence	The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.

Primary

Cmax: Maximum Concentration in a Dosing Interval for Total IgG

Posted

Mean

Standard Deviation

milligrams per decilitre (mg/dL)

Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours, and 4, 7, 14, 21 and 28 days post-infusion (up to 4 weeks)

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
OG001	IVIG-PEG	Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.

Secondary

Rate of Serious Bacterial Infections (SBIs)

The rate of SBI events per participant per year during treatment was calculated as the total number of SBI events divided by the total duration of exposure in years across all participants. The 2-sided 98% confidence interval (CI) was determined from a generalized linear model for Poisson regression for the log-transformed number of events with log-transformed duration of exposure in years as an offset variable.

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).

Posted

Number

98% Confidence Interval

rate of events per participant per year

Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.

Secondary

Rate of Events Per Participant Per Year in Participants With Any Kind of Infection

Rate of events per participant per year is calculated as the total number of events divided by the total duration of exposure in years across all participants. Any kind of infections included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the Investigator.

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or Gamunex-C).

Posted

Number

95% Confidence Interval

rate of events per participant per year

Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.

Secondary

Rate of Days Per Person Per Year That Participants Were on Antibiotics

Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic.

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).

Posted

Number

95% Confidence Interval

rate of days per participant per year

Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
OG001	IVIG-PEG

Secondary

Number of Participants Hospitalized Due to Infection

Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours.

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).

Posted

Count of Participants

Participants

Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
OG001	IVIG-PEG	Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.

Secondary

Rate of Days of Work/School/Daily Activities Missed Per Participant Due to Infections and Their Treatment

Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants.

The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).

Posted

Number

95% Confidence Interval

rate of days missed/participant per year

Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months

ID	Title	Description
OG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
OG001	IVIG-PEG

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gamunex-C	Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.	0	33	1	33	20	33
EG001	IVIG-PEG	Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.	0	32	0	32	23	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment		EG0001 affected33 at risk EG0010 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Methylenetetrahydrofolate Reductase Gene Mutation	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Chorioretinal disorder	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Eye Inflammation	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Eye Pruritus	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0013 affected32 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Administration site bruise	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Application site rash	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Injection site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Polyp	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Nonalcoholic fatty liver disease	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Multiple allergies	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Seasonal Allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0011 affected32 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected33 at risk EG0014 affected32 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Fungal Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0011 affected32 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Paronychia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Periodontitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 affected33 at risk EG0014 affected32 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0012 affected32 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0011 affected32 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Traumatic iritis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Free Prostate-specific Antigen Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Low Density Lipoprotein Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
SARS-CoV-2 Test Positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Failure to Thrive	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Hypoferritinaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected33 at risk EG0010 affected32 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0012 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected33 at risk EG0015 affected32 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Nasal Mucosal Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Sinus Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0012 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected33 at risk EG0011 affected32 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected33 at risk EG0010 affected32 at risk

First MCP Posted Date

ID	Term
D000081207	Primary Immunodeficiency Diseases

ID	Term
C558471	Hizentra

Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases