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| ID | Type | Description | Link |
|---|---|---|---|
| 1472 | Other Identifier | CSL Behring | |
| 2008-000830-30 | EudraCT Number |
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This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental | Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Serum IgG Trough Levels | The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics. | Up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) | The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director, Clinical R&D | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Paris | 75743 | France | |||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24412910 | Result | Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26. |
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Subjects who had previously participated in the pivotal study ZLB06_001CR (NCT00542997) were enrolled in the extension study ZLB07_002CR.
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| ID | Title | Description |
|---|---|---|
| FG000 | IgPro20 | Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Up to 42 months |
| Annualized Rate of Infection Episodes | The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | Up to 42 months |
| Number of Infection Episodes | Total number of infections for the specified analysis population | Up to 42 months |
| Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days. | Up to 42 months |
| Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections | Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population | Up to 42 months |
| Annualized Rate of Hospitalization Due to Infections | The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days. | Up to 42 months |
| Number of Days of Hospitalization Due to Infections | Total number of days of hospitalization due to infections for the specified analysis population | Up to 42 months |
| Use of Antibiotics for Infection Prophylaxis and Treatment | Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days. | Up to 42 months |
| Health Related Quality of Life (Short Form 36 Health Survey) | The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state. | At baseline and at the last available post-baseline observation for each subject (up to 42 months) |
| Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit. | The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months). |
| Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit. | The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis. | At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months). |
| Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion | The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. | Up to 42 months |
| Berlin |
| 13353 |
| Germany |
| Study Site | Freiburg im Breisgau | 79095 | Germany |
| Study Site | Leipzig | 04129 | Germany |
| Study Site | Mainz | 55131 | Germany |
| Study Site | Warsaw | Poland |
| Study Site | Cluj-Napoca | 400162 | Romania |
| Study Site | Timișoara | 300011 | Romania |
| Study Site | Barcelona | 08036 | Spain |
| Study Site | Seville | 41013 | Spain |
| Study Site | Gothenburg | 41685 | Sweden |
| Study Site | Bern | 3010 | Switzerland |
| Study Site | London | EC1A7BE | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IgPro20 | Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | 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 | Total Serum IgG Trough Levels | The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics. | The "all treated" (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the "Full Analysis/intention-to-treat" (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Mean | Standard Deviation | g/L | Up to 42 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) | The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs. | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | SBIs per subject year | Up to 42 months | Subject Study Days | Participants |
|
| |||||||||||||||||||||||||
| Secondary | Annualized Rate of Infection Episodes | The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | 95% Confidence Interval | infection episodes per subject year | Up to 42 months | Subject Study Days | Participants |
|
| ||||||||||||||||||||||||
| Secondary | Number of Infection Episodes | Total number of infections for the specified analysis population | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | infection episodes | Up to 42 months |
|
| |||||||||||||||||||||||||||
| Secondary | Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days. | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | days per subject year | Up to 42 months | Subject Diary Days | Participants |
|
| |||||||||||||||||||||||||
| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections | Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | days | Up to 42 months |
|
| |||||||||||||||||||||||||||
| Secondary | Annualized Rate of Hospitalization Due to Infections | The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days. | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | days per subject year | Up to 42 months | Subject Diary Days | Participants |
|
| |||||||||||||||||||||||||
| Secondary | Number of Days of Hospitalization Due to Infections | Total number of days of hospitalization due to infections for the specified analysis population | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | days | Up to 42 months |
|
| |||||||||||||||||||||||||||
| Secondary | Use of Antibiotics for Infection Prophylaxis and Treatment | Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days. | The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available. | Posted | Number | days per subject year | Up to 42 months | Subject Study Days | Participants |
|
| |||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (Short Form 36 Health Survey) | The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state. | The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age. | Posted | Median | Full Range | score on a scale | At baseline and at the last available post-baseline observation for each subject (up to 42 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit. | The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion. | Posted | Number | participants | At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months). |
|
| |||||||||||||||||||||||||||
| Secondary | Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit. | The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis. | The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion. | Posted | Number | participants | At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months). |
|
| |||||||||||||||||||||||||||
| Secondary | Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion | The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. | The AT safety data set comprised all subjects treated with IgPro20 during any study period. | Posted | Number | AEs per infusion | Up to 42 months | Number of Infusions | Participants |
|
|
AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IgPro20 | Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997). | 14 | 40 | 39 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (14.1) | Systematic Assessment | This AE was collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions. |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Enterobiasis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
| 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 |
|---|---|
| C558471 | Hizentra |
| D007074 | Immunoglobulin G |
| D011392 | Proline |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ≥ 65 years |
|
| Subject Study Days |
|
|
| Subject Study Days |
|
|
|
| Subject Diary Days |
|
|
|
| Subject Diary Days |
|
|
|
| Subject Study Days |
|
|
|
|
|
|
| Number of Infusions |
|
|