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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003290-15 | EudraCT Number |
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Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) who complete the entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on self-administration of IGSC 20% by the clinical site personnel.
This is a prospective, multi-center, open-label, single-arm, efficacy, PK, safety and tolerability study of IGSC 20% in subjects with PI. Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered IGSC 20% who complete the entire study.
This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly doses).
Previous Regimen Phase: Subjects will be infused with their current ongoing ("previous regimen") intravenous immune globulin/subcutaneous immune globulin (IVIG/SCIG) regimen (pIV/pSC) in the clinic to obtain 2 trough immunoglobulin G (IgG) levels (obtained prior to each pIV/pSC infusion) on each subject's "previous regimen".
20% IGSC Treatment Stage 1: The first dose of IGSC 20% will be administered at the clinical site immediately after Baseline assessments are complete (SC#1). All subjects will receive 13 IGSC 20% infusions at weekly intervals. IgG trough blood levels will be measured at all (except SC#3) study visits All other doses of IGSC 20% may be infused at home (once properly trained) or in the clinic. The Treatment Stage 1 dose will continue into IGSC 20% Treatment Stage 2.
IGSC 20% Treatment Stage 2: The IGSC 20% dose (mg/kg) will remain constant with no dose adjustment permitted in this phase, unless it is absolutely medically necessary. While all subjects will have a SC#17 clinic visit and standard assessments, serial pharmacokinetics (PK) sampling will only be performed in a subset of adult subjects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGSC 20% | Experimental | 13 doses of IGSC 20% in Treatment Stage 1 and 39 doses of IGSC 20% in Treatment Stage 2 for a total of 52 doses if IGSC 20% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGSC 20% | Biological | Weekly administration of IGSC 20% via intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Serious Bacterial Infection (SBI) Per Participant Per Year | The rate of SBI events per participant per year during IGSC 20% 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. | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Trough Total IgG Concentration | Mean trough total IgG concentration during the previous regimen phase was calculated as the average of the trough concentrations at the previous IVIG (pIV)#1 and pIV#2 visits for participants entering the study on a previous IVIG regimen, or at the previous subcutaneous immune globulin (SCIG) (pSC)#1 and baseline/SC#1 visits for participants entering the study on a previous SCIG regimen. Mean trough total IgG concentration during the IGSC 20% phase was calculated as the average of all steady state trough concentrations measured during the IGSC 20% treatment stage 2 at the visits corresponding to Weeks 17, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 53. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wesley Medical Research | Auchenflower | 4066 | Australia | |||
| Royal Melbourne Hospital |
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Participants had no SBI within last 3 months prior to screening and were on immunoglobulin G (IgG) replacement therapy (stable regimen via intravenous [IV] or subcutaneous [SC] infusion) for ≥3 consecutive months prior to screening. Participants receiving IVIG prior to study entry must have received a dosage of ≥200 mg/kg per infusion.
Participants with primary immunodeficiency (PI) requiring IgG replacement were enrolled. Study has 3 stages: Screening/Previous Regimen Phase, Treatment Stage 1 and 2. Total 62 participants entered Previous Regimen Phase, of which 61 entered in Treatment Stage 1 to receive IGSC 20%. Study was conducted in 8 countries from June 2016 to May 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | IGSC 20% | Following the previous regimen phase (screening), participants were enrolled to receive 13 immune globulin subcutaneous (human), 20% caprylate/chromatography purified (IGSC 20%) infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 milligram per kilogram per week (mg/kg/week) if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and at the Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Stage 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2016 | May 15, 2020 |
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| Previous Regimen Phase: 2 timepoints pre-dose of pIV or pSC between Screening and Baseline (up to 8 weeks). IGSC 20% Phase: Pre-dose of IGSC 20% at Baseline (Week 1), Weeks 2, 5, 9, 13, 17, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Week 53 |
| Rate of Infection of Any Kind Per Participant Per Year | The total number of infections of any kind (serious/non-serious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea, etc.) as determined by the investigator were evaluated. The rate of infection events per participant per year during IGSC 20% treatment was calculated as the total number of infection events divided by the total duration of exposure in years across all participants. The 2-sided 95% 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. | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| Rate of Days on Antibiotics Per Participants Per Year | The rate of days on antibiotics per participants per year during IGSC 20% treatment was calculated as the total number of days on antibiotic divided by the total duration of exposure in years across all participants. The 2-sided 95% CI was determined from a generalized linear model for poisson regression for the log transformed number of days with log-transformed duration of exposure in years as an offset variable. | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| Rate of Hospitalization Due to Infection Per Participants Per Year | The rate of hospitalization due to infection events per participant per year during IGSC 20% treatment was calculated as the total number of hospitalization due to infection events divided by the total duration of exposure in years across all participants. The 2-sided 95% 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. | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| Rate of Days of Work/School/Daily Activities Missed Per Participants Per Year Due to Infections and Related Treatment | The rate of days of work, school or daily activities missed per participant per year during IGSC 20% treatment was calculated as the total number of days of work/school/daily activities missed divided by the total duration of exposure in years across all participants. The 2-sided 95% CI was determined from a generalized linear model for poisson regression for the log-transformed number of days with log transformed duration of exposure in years as an offset variable. | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| Parkville |
| 3050 |
| Australia |
| University Hospital | Hradec Králové | 50005 | Czechia |
| CHU de Montpellier | Montpellier | 34295 | France |
| Klinikum Dortmund gGmbH | Dortmund | 44137 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Children's Hospital at Municipal Hospital St. Georg | Leipzig | 04129 | Germany |
| University Hospital of Mainz | Mainz | 55131 | Germany |
| Asklepios Klinik Sankt Augustin | Sankt Augustin | 53757 | Germany |
| United St Istvan and St Laszlo Hospital | Budapest | Hungary |
| Josa Andras County Hospital | Nyiregyháza | H-4400 | Hungary |
| The Children's Memorial Health Institute | Warsaw | 4736 | Poland |
| Hospital Universitario Vall d'Hebron | Barcelona | 08025 | Spain |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Universitari Sant Joan de Déu | Barcelona | 08950 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital 12 Octubre | Madrid | 28041 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Stockholm | Stockholm | SE-14186 | Sweden |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| St Bartholomew's Hospital | London | E1 2ES | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Stage 2 |
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The efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
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| ID | Title | Description |
|---|---|---|
| BG000 | IGSC 20% | Following the previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and at the Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Subject Entry Status | Count of Participants | Participants |
|
| 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 | Rate of Serious Bacterial Infection (SBI) Per Participant Per Year | The rate of SBI events per participant per year during IGSC 20% 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. | Analysis was performed on the efficacy evaluable population which included all participants who received at least 1 dose of IGSC 20%. | Posted | Number | 98% Confidence Interval | Rate of events per participant per year | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Trough Total IgG Concentration | Mean trough total IgG concentration during the previous regimen phase was calculated as the average of the trough concentrations at the previous IVIG (pIV)#1 and pIV#2 visits for participants entering the study on a previous IVIG regimen, or at the previous subcutaneous immune globulin (SCIG) (pSC)#1 and baseline/SC#1 visits for participants entering the study on a previous SCIG regimen. Mean trough total IgG concentration during the IGSC 20% phase was calculated as the average of all steady state trough concentrations measured during the IGSC 20% treatment stage 2 at the visits corresponding to Weeks 17, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 53. | Analysis was performed on the IgG population which consisted of all participants who received any amount of IGSC 20% and had total IgG concentration data to facilitate the comparison of mean trough IgG concentration during the IGSC 20% phase versus the pre-treatment phase. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Previous Regimen Phase: 2 timepoints pre-dose of pIV or pSC between Screening and Baseline (up to 8 weeks). IGSC 20% Phase: Pre-dose of IGSC 20% at Baseline (Week 1), Weeks 2, 5, 9, 13, 17, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Week 53 |
| |||||||||||||||||||||||||||||||||
| Secondary | Rate of Infection of Any Kind Per Participant Per Year | The total number of infections of any kind (serious/non-serious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea, etc.) as determined by the investigator were evaluated. The rate of infection events per participant per year during IGSC 20% treatment was calculated as the total number of infection events divided by the total duration of exposure in years across all participants. The 2-sided 95% 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. | Analysis was performed on the efficacy evaluable population which included all participants who received at least 1 dose of IGSC 20%. | Posted | Number | 95% Confidence Interval | Rate of events per participant per year | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| |||||||||||||||||||||||||||||||||
| Secondary | Rate of Days on Antibiotics Per Participants Per Year | The rate of days on antibiotics per participants per year during IGSC 20% treatment was calculated as the total number of days on antibiotic divided by the total duration of exposure in years across all participants. The 2-sided 95% CI was determined from a generalized linear model for poisson regression for the log transformed number of days with log-transformed duration of exposure in years as an offset variable. | Analysis was performed on the efficacy evaluable population which included all participants who received at least 1 dose of IGSC 20%. | Posted | Number | 95% Confidence Interval | Rate of days per participant per year | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| |||||||||||||||||||||||||||||||||
| Secondary | Rate of Hospitalization Due to Infection Per Participants Per Year | The rate of hospitalization due to infection events per participant per year during IGSC 20% treatment was calculated as the total number of hospitalization due to infection events divided by the total duration of exposure in years across all participants. The 2-sided 95% 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. | Analysis was performed on the efficacy evaluable population which included all participants who received at least 1 dose of IGSC 20%. | Posted | Number | 95% Confidence Interval | Rate of events per person per year | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
| |||||||||||||||||||||||||||||||||
| Secondary | Rate of Days of Work/School/Daily Activities Missed Per Participants Per Year Due to Infections and Related Treatment | The rate of days of work, school or daily activities missed per participant per year during IGSC 20% treatment was calculated as the total number of days of work/school/daily activities missed divided by the total duration of exposure in years across all participants. The 2-sided 95% CI was determined from a generalized linear model for poisson regression for the log-transformed number of days with log transformed duration of exposure in years as an offset variable. | Analysis was performed on the efficacy evaluable population which included all participants who received at least 1 dose of IGSC 20%. | Posted | Number | 95% Confidence Interval | Rate of days missed per person per year | IGSC 20% Treatment Stage 1: Week 1 to 13; IGSC 20% Treatment Stage 2: Week 14 to 53; IGSC 20% Overall: Week 1 to 53 |
|
Treatment-emergent adverse events (TEAEs) were collected from the beginning of treatment administration with IGSC 20% (Baseline/Week 1) until the Final Visit (Week 53). Up to 1 year overall.
TEAEs are presented for the safety population which included all participants who received any amount of IGSC 20%.
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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 | IGSC 20% Overall | Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. | 0 | 61 | 7 | 61 | 49 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Medical device site joint pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhonda Griffin | Grifols Therapeutics LLC | 919-316-6693 | rhonda.griffin@grifols.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2019 | May 15, 2020 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D002210 | Caprylates |
| D002845 | Chromatography |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Unknown |
|
| OG001 | Previous Regimen | Participants were required to attend the clinic for infusion with their previous ongoing ("previous regimen") IVIG/SCIG regimen (pIV/pSC) to obtain 2 trough IgG levels (obtained prior to each pIV/pSC infusion) on each participant's "previous regimen". Trough levels for total IgG determined during the Previous Regimen Phase were used to confirm final eligibility for participants entering the study to receive treatment with IGSC 20% (must be ≥500 milligrams per deciliter [mg/dL]). |
|
|
| IGSC 20% Treatment Stage 2 |
Following treatment stage 1, participants received 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52. The IGSC 20% dose (mg/kg) remained constant with no dose adjustment permitted in this phase, unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
| OG002 | IGSC 20% Overall | Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
|
|
| OG002 | IGSC 20% Overall | Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
|
|
| OG002 | IGSC 20% Overall | Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
|
|
Following treatment stage 1, participants received 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52. The IGSC 20% dose (mg/kg) remained constant with no dose adjustment permitted in this phase, unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
| OG002 | IGSC 20% Overall | Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53. |
|
|