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The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune globulin subcutaneous (Human) | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Median of the Individual Subject's Rate of Adverse Events (AEs) Per 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]). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Rate of AEs Per 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Infection Episodes (Serious and Non-serious) | 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. | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Midori Kobayashi | CSL Behring K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study site | Nagoya | Aichi Pref. | 466-8560 | Japan | ||
| Study site |
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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Median of the Individual Subject's Rate of Adverse Events (AEs) Per 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]). | The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion. | Posted | Median | Full Range | AEs per infusion | 24 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalitis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| C558471 | Hizentra |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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|
|
| 24 weeks |
| Number of Subjects With Newly Developing or Worsening AEs | 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]). | 24 weeks |
| Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good' | 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. | 24 to 72 hours after infusion |
| 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 | 24 weeks |
| Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) | 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. | 24 weeks |
| Number of Infection Episodes (Serious and Non-serious) | 24 weeks |
| Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections. | Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections. | 24 weeks |
| Number of Days of Hospitalization Due to Infections. | Median number of days of hospitalization due to infections. | 24 weeks |
| Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | Median number of days of use of antibiotics for infection prophylaxis and/or treatment | 24 weeks |
| Chiba |
| Chiba Pref. |
| 260-8677 |
| Japan |
| Study site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Study site | Gifu | Gifu Pref. | 502-8558 | Japan |
| Study site | Sapporo | Hokkaido | 060-8648 | Japan |
| Study site | Moriguchi | Osaka | 570-8507 | Japan |
| Study site | Koshigaya | Saitama Pref. | 343-8555 | Japan |
| Study site | Tokorozawa | Saitama Pref. | 359-8513 | Japan |
| Study site | Bunkyō City | Tokyo Metropolitan | 113-8519 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Rate of AEs Per 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. | The AT set comprised all subjects receiving at least 1 IgPro20 infusion. | Posted | Number | AEs per infusion | 24 weeks | Infusions | Participants |
|
|
|
| Secondary | Number of Subjects With Newly Developing or Worsening AEs | 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]). | The AT set comprised all subjects receiving at least 1 IgPro20 infusion. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good' | 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. | The FAS comprised all subjects receiving at least 1 IgPro20 infusion. | Posted | Number | percentage of infusions | 24 to 72 hours after infusion |
|
|
|
| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | g/L | 24 weeks |
|
|
|
| Secondary | Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) | 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. | 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. | Posted | Number | SBIs per subject year | 24 weeks | Total Study Days | Participants |
|
|
|
|
| Secondary | Number of Infection Episodes (Serious and Non-serious) | 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. | Posted | Number | infection episodes | 24 weeks |
|
|
|
| Secondary | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections. | Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections. | 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. | Posted | Median | Full Range | days | 24 weeks |
|
|
|
| Secondary | Number of Days of Hospitalization Due to Infections. | Median number of days of hospitalization due to infections. | 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. | Posted | Median | Full Range | days | 24 weeks |
|
|
|
| Secondary | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | Median number of days of use of antibiotics for infection prophylaxis and/or treatment | 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. | Posted | Median | Full Range | days | 24 weeks |
|
|
|
| Other Pre-specified | Rate of Infection Episodes (Serious and Non-serious) | 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. | 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. | Posted | Number | infection episodes per subject year | 24 weeks | Total Study Days | Participants |
|
|
|
| 1 |
| 23 |
| 20 |
| 23 |
| Injection site induration | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Severe AEs |
|
| Not related or unlikely related AEs |
|
| At least possibly related AEs |
|
| Title | Measurements |
|---|---|
|
| Severe AEs |
|
| Not related or unlikely related |
|
| At least possibly related |
|
| Change from baseline to the completion vist |
|
| 0.00 |
| 1-Sided |
| 99 |
| 0.523 |
| No |
| Superiority or Other |