Trial Outcomes & Findings for Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) (NCT NCT01458171)

NCT ID: NCT01458171

Last Updated: 2013-04-09

Results Overview

The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related \[i.e., possibly related, probably related, or related\]).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2013-04-09

Participant Flow

This multicenter study enrolled subjects at nine study centers in Japan who had participated in the preceding pivotal study ZLB06_002CR (CT.gov identifier: NCT01199705).

Only subjects participating in the preceding pivotal study ZLB06_002CR (NCT01199705) were eligible. The enrolment visit of this study was on the same day as the completion visit of the preceding pivotal study ZLB06_002CR.

Participant milestones

Measure	IgPro20 Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	IgPro20 Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).
Overall Study Adverse Event	1

Baseline Characteristics

Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Baseline characteristics by cohort

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).
Age Continuous	20.8 years STANDARD_DEVIATION 13.68 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion.

The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion All AEs	0.167 AEs per infusion Interval 0.0 to 1.71	—
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion Mild AEs	0.125 AEs per infusion Interval 0.0 to 1.71	—
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion Moderate AEs	0 AEs per infusion Interval 0.0 to 0.04	—
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion Severe AEs	0 AEs per infusion Interval 0.0 to 1.0	—
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion Not related or unlikely related AEs	0.125 AEs per infusion Interval 0.0 to 0.75	—
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion At least possibly related AEs	0 AEs per infusion Interval 0.0 to 1.0	—

SECONDARY outcome

Timeframe: 24 weeks

Population: The AT set comprised all subjects receiving at least 1 IgPro20 infusion.

The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.

Outcome measures

Measure	IgPro20 n=529 Infusions Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Overall Rate of AEs Per Infusion Mild AEs	0.342 AEs per infusion	—
Overall Rate of AEs Per Infusion Moderate AEs	0.002 AEs per infusion	—
Overall Rate of AEs Per Infusion Severe AEs	0.002 AEs per infusion	—
Overall Rate of AEs Per Infusion Not related or unlikely related AEs	0.210 AEs per infusion	—
Overall Rate of AEs Per Infusion At least possibly related AEs	0.136 AEs per infusion	—
Overall Rate of AEs Per Infusion All AEs	0.346 AEs per infusion	—

SECONDARY outcome

Timeframe: 24 weeks

Population: The AT set comprised all subjects receiving at least 1 IgPro20 infusion.

Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Number of Subjects With Newly Developing or Worsening AEs All AEs	22 participants	—
Number of Subjects With Newly Developing or Worsening AEs Mild AEs	21 participants	—
Number of Subjects With Newly Developing or Worsening AEs Moderate AEs	1 participants	—
Number of Subjects With Newly Developing or Worsening AEs Severe AEs	1 participants	—
Number of Subjects With Newly Developing or Worsening AEs Not related or unlikely related	12 participants	—
Number of Subjects With Newly Developing or Worsening AEs At least possibly related	10 participants	—

SECONDARY outcome

Timeframe: 24 to 72 hours after infusion

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion.

Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as "very good", "good", "fair", or "poor". The reported percentage represents the percentage of subjects with local tolerability assessments of "very good" or "good" at any given study infusion.

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'	85.4 percentage of infusions	—

SECONDARY outcome

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) comprised all subjects receiving at least 1 IgPro20 infusion. The Per Protocol Set (PPS) comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=19 Participants The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
IgG Trough Level Baseline	7.469 g/L Standard Deviation 1.3943	7.586 g/L Standard Deviation 1.3363
IgG Trough Level Completion visit	8.914 g/L Standard Deviation 4.0502	8.227 g/L Standard Deviation 1.5458
IgG Trough Level Change from baseline to the completion vist	1.445 g/L Standard Deviation 3.4379	0.642 g/L Standard Deviation 0.7687

SECONDARY outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.

Outcome measures

Measure	IgPro20 n=3739 Total Study Days Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=3214 Total Study Days The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)	0.00 SBIs per subject year	0.00 SBIs per subject year

SECONDARY outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=19 Participants The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Number of Infection Episodes (Serious and Non-serious)	43 infection episodes	38 infection episodes

SECONDARY outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=19 Participants The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.	0 days Interval 0.0 to 12.0	0 days Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

Median number of days of hospitalization due to infections.

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=19 Participants The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Number of Days of Hospitalization Due to Infections.	0 days Interval 0.0 to 11.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

Median number of days of use of antibiotics for infection prophylaxis and/or treatment

Outcome measures

Measure	IgPro20 n=23 Participants Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=19 Participants The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment	91.5 days Interval 6.0 to 170.0	154.0 days Interval 6.0 to 170.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.

The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.

Outcome measures

Measure	IgPro20 n=3739 Total Study Days Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).	IgPro20 - PPS n=3214 Total Study Days The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
Rate of Infection Episodes (Serious and Non-serious)	4.20 infection episodes per subject year	4.32 infection episodes per subject year

Adverse Events

IgPro20

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	IgPro20 n=23 participants at risk Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).
Nervous system disorders Encephalitis	4.3% 1/23 • Number of events 1 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.

Other adverse events

Measure	IgPro20 n=23 participants at risk Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).
Gastrointestinal disorders Dental caries	17.4% 4/23 • Number of events 4 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
General disorders Injection site induration	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
General disorders Injection site pain	21.7% 5/23 • Number of events 37 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
General disorders Pyrexia	8.7% 2/23 • Number of events 4 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Bronchitis	8.7% 2/23 • Number of events 3 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Conjunctivitis infective	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Nasopharyngitis	26.1% 6/23 • Number of events 13 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Pharyngitis	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Sinusitis	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Infections and infestations Upper respiratory tract infection	21.7% 5/23 • Number of events 8 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Injury, poisoning and procedural complications Arthropod bite	13.0% 3/23 • Number of events 13 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Musculoskeletal and connective tissue disorders Pain in extremity	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Nervous system disorders Headache	13.0% 3/23 • Number of events 8 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Dermatitis contact	8.7% 2/23 • Number of events 2 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Eczema	26.1% 6/23 • Number of events 7 • For the duration of the study, that is, 24 weeks. Only AEs starting at or after the first study drug infusion are included. The AT set comprised all subjects receiving at least 1 IgPro20 infusion. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.

Additional Information

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