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The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.
Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care.
In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.
For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.
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| Measure | Description | Time Frame |
|---|---|---|
| Infusion Time of Multigam IV 5% and Multigam IV 10% | Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval. | Up to 1 month after Multigam 5% infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisation Time of Multigam IV 5% and Multigam IV 10% | Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval. | Up to 1 month after Multigam 5% infusion |
| IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration |
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Inclusion Criteria:
Exclusion Criteria:
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30 patients with an immunodeficiency secondary to a hematologic disorder
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| Name | Affiliation | Role |
|---|---|---|
| Michel Delforge, MD PhD | UZ Leuven Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | Vlaams-Brabant | 3000 | Belgium |
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This study enrolled 30 patients with an immunodeficiency secondary to a hematologic disorder requiring immunoglobin substitution therapy from 1 academic center in Belgium. The last patient completed in December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later. Dosing was set at 0.4 g/kg for both infusions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Multigam 5% Infusion (Baseline) |
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| Multigam 10% Infusion (3-4 Weeks Later) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Baseline characteristics of the study population (30 participants). |
| 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 |
| 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 | Infusion Time of Multigam IV 5% and Multigam IV 10% | Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval. | Posted | Mean | 95% Confidence Interval | hour | Up to 1 month after Multigam 5% infusion |
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Up to 72 after each infusion
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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 | Multigam 5% Infusion | 30 participants who received Multigam 5% intravenous immunoglobulin (IVIg). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Datamanager | UZ Leuven | +3216346880 | jonas.vanham@uzleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2017 | Oct 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria. Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion. |
| Up to 72 after each infusion |
| Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation. | During each infusion (up to 1 day) |
| Patient Satisfaction Questionnaire. | Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse. Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]: Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%. | End of study (after Multigam 10% infusion) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Haematological disorder | Count of Participants | Participants |
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| Time between first IVIg infusion and start of study | Mean | Standard Deviation | years |
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| First Multigam Dosage | Median | Full Range | gram |
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| Secondary | Hospitalisation Time of Multigam IV 5% and Multigam IV 10% | Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval. | Posted | Mean | 95% Confidence Interval | hour | Up to 1 month after Multigam 5% infusion |
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| Secondary | IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria. Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion. | Posted | Mean | 95% Confidence Interval | IVIg-related AEs per patient | Up to 72 after each infusion |
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|
|
| Secondary | Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation. | Posted | Mean | 95% Confidence Interval | Nursing actions per patient | During each infusion (up to 1 day) |
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| Secondary | Patient Satisfaction Questionnaire. | Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse. Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]: Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%. | Row 3: 1 patient was unable to assess the question | Posted | Median | Full Range | score on a scale | End of study (after Multigam 10% infusion) |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Multigam 10% Infusion | 30 participants who received Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks after their Multigam 5% infusion. | 0 | 30 | 0 | 30 | 8 | 30 |
| Fatigue | General disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Non-systematic Assessment |
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| Infusion related reaction | General disorders | CTCAE v4.03 | Non-systematic Assessment | Nausea |
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| Infusion related reaction | General disorders | CTCAE v4.03 | Non-systematic Assessment | Chills |
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| Infusion related reaction | General disorders | CTCAE v4.03 | Non-systematic Assessment | Fever |
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| Question 3 |
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| Question 4 |
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