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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
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This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Cohort1 will include the participants who have been transitioned to CUVITRU at the time of enrollment in the study. |
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| Cohort 2 | Cohort 2 will include participants 6 months (±2 weeks) after CUVITRU initiation. |
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| Cohort 3 | Cohort 3 will include participants 12 months (-1 or +2 months) after CUVITRU initiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUVITRU | Biological | CUVITRU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infusion parameter 1: Cohort 1-Start of data collection | Median infusion volume per site | Baseline |
| Infusion parameter 1: Cohort 1- Month 3 | Median infusion volume per site | Month 3 |
| Infusion parameter 1: Cohort 1- Month 6 | Median infusion volume per site | Month 6 |
| Infusion parameter 1: Cohort 1- 12 Month final follow-up | Median infusion volume per site | 12 Month final follow-up |
| Infusion parameter 1: Cohort 2- Start of data collection | Median infusion volume per site | Baseline |
| Infusion parameter 1: Cohort 2- 12 Month final follow-up | Median infusion volume per site | 12 Month final follow-up |
| Infusion parameter 1.1: Cohort 1- Start of data collection | Median infusion volume per infusion | Baseline |
| Infusion parameter 1.1: Cohort 1- Month 3 | Median infusion volume per infusion | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Infusion parameter 4.1: Cohort 1- Start of data collection | Median maximal infusion rate per site | Baseline |
| Infusion parameter 4.1: Cohort 1- Month 3 | Median maximal infusion rate per site |
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Inclusion Criteria (The participant will not be considered eligible for the study without meeting all of the criteria below):
Exclusion Criteria (Participants are excluded from the study if any of the following criteria are met):
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Data will be collected on approximately 500 participants with primary immunodeficiency (PID) and secondary immunodeficiency (SID) requiring Immunoglobulin G (IgG) replacement therapy across 8-10 sites in Canada (excluding Quebec). Any specific number of participants in each cohort is not a requirement.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of McMaster | Hamilton | Ontario | L8S 4L8 | Canada | ||
| Grand River Allergy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35934726 | Derived | Keith PK, Cowan J, Kanani A, Kim H, Lacuesta G, Lee JK, Chen J, Park M, Gladiator A. Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. Allergy Asthma Clin Immunol. 2022 Aug 7;18(1):70. doi: 10.1186/s13223-022-00709-8. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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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 |
|---|---|
| C558471 | Hizentra |
| D012996 | Solutions |
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
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| Infusion parameter 1.1: Cohort 1- Month 6 |
Median infusion volume per infusion |
| Month 6 |
| Infusion parameter 1.1: Cohort 1- 12 Month final follow-up | Median infusion volume per infusion | 12 Month final follow-up |
| Infusion parameter 1.1: Cohort 2- Start of data collection | Median infusion volume per infusion | Baseline |
| Infusion parameter 1.1: Cohort 2- 12 Month final follow-up | Median infusion volume per infusion | 12 Month final follow-up |
| Infusion parameter 2: Cohort 1- Start of data collection | Median number of infusion sites | Baseline |
| Infusion parameter 2: Cohort 1- Month 3 | Median number of infusion sites | Month 3 |
| Infusion parameter 2: Cohort 1- Month 6 | Median number of infusion sites | Month 6 |
| Infusion parameter 2: Cohort 1- 12 Month final follow-up | Median number of infusion sites | 12 Month final follow-up |
| Infusion parameter 2: Cohort 2- Start of data collection | Median number of infusion sites | Baseline |
| Infusion parameter 2: Cohort 2- 12 Month final follow-up | Median number of infusion sites | 12 Month final follow-up |
| Infusion parameter 3: Cohort 1- Start of data collection | Median infusion duration | Baseline |
| Infusion parameter 3: Cohort 1- Month 3 | Median infusion duration | Month 3 |
| Infusion parameter 3: Cohort 1- Month 6 | Median infusion duration | Month 6 |
| Infusion parameter 3: Cohort 1- 12 Month final follow-up | Median infusion duration | 12 Month final follow-up |
| Infusion parameter 3: Cohort 2- Start of data collection | Median infusion duration | Baseline |
| Infusion parameter 3: Cohort 2- 12 Month final follow-up | Median infusion duration | 12 Month final follow-up |
| Infusion parameter 3.1: Cohort 1- Month 3 Follow-up | Median number of infusions to reach participant's maximum infusion volume | Month 3 |
| Infusion parameter 3.1: Cohort 1- Month 6 Follow-up | Median number of infusions to reach participant's maximum infusion volume | Month 6 |
| Infusion parameter 3.1: Cohort 1- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion volume | 12 Month final follow-up |
| Infusion parameter 3.1: Cohort 2- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion volume | 12 Month final follow-up |
| Infusion parameter 3.2: Cohort 1- Start of data collection | Median number of infusions per month per participant | Baseline |
| Infusion parameter 3.2: Cohort 1- Month 3 | Median number of infusions per month per participant | Month 3 |
| Infusion parameter 3.2: Cohort 1- Month 6 | Median number of infusions per month per participant | Month 6 |
| Infusion parameter 3.2: Cohort 1- 12 Month final follow-up | Median number of infusions per month per participant | 12 Month final follow-up |
| Infusion parameter 3.2: Cohort 2- Start of data collection | Median number of infusions per month per participant | Baseline |
| Infusion parameter 3.2: Cohort 2- 12 Month final follow-up | Median number of infusions per month per participant | 12 Month final follow-up |
| Infusion parameter 3.3: Cohort 1- Start of data collection | Median number of infusions to reach final dose interval per participant | Baseline |
| Infusion parameter 3.3: Cohort 1- Month 3 | Median number of infusions to reach final dose interval per participant | Month 3 |
| Infusion parameter 3.3: Cohort 1- Month 6 | Median number of infusions to reach final dose interval per participant | Month 6 |
| Infusion parameter 3.3: Cohort 1- 12 Month final follow-up | Median number of infusions to reach final dose interval per participant | 12 Month final follow-up |
| Infusion parameter 3.3: Cohort 2- Start of data collection | Median number of infusions to reach final dose interval per participant | Baseline |
| Infusion parameter 3.3: Cohort 2- 12 Month final follow-up | Median number of infusions to reach final dose interval per participant | 12 Month final follow-up |
| Infusion parameter 1: Cohort 3- 12 Month Final Follow-up | Median infusion volume per site. | 12 Month final follow-up |
| Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up | Median infusion volume per infusion. | 12 Month final follow-up |
| Infusion parameter 2: Cohort 3- 12 Month final follow-up | Median number of infusion sites. | 12 Month final follow-up |
| Infusion parameter 3: Cohort 3- 12 Month final follow-up | Median infusion duration. | 12 Month final follow-up |
| Infusion parameter 3.1: Cohort 3- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion volume (infusion rate) | 12 Month final follow-up |
| Infusion parameter 3.2: Cohort 3- 12 Month final follow-up | Median number of infusions per month per participant | 12 Month final follow-up |
| Infusion parameter 3.3: Cohort 3- 12 Month final follow-up | Median number of infusions to reach final dose interval per participant | 12 Month final follow-up |
| Month 3 |
| Infusion parameter 4.1: Cohort 1- Month 6 | Median maximal infusion rate per site | Month 6 |
| Infusion parameter 4.1: Cohort 1- 12 Month final follow-up | Median maximal infusion rate per site | 12 Month final follow-up |
| Infusion parameter 4.1: Cohort 2- Start of data collection | Median maximal infusion rate per site | Baseline |
| Infusion parameter 4.1: Cohort 2- 12 Month final follow-up | Median maximal infusion rate per site | 12 Month final follow-up |
| Infusion parameter 4.2: Cohort 1- Start of data collection | Number of infusions that are discontinued, slowed, or interrupted | Baseline |
| Infusion parameter 4.2: Cohort 1- Month 3 | Number of infusions that are discontinued, slowed, or interrupted | Month 3 |
| Infusion parameter 4.2: Cohort 1- Month 6 | Number of infusions that are discontinued, slowed, or interrupted | Month 6 |
| Infusion parameter 4.2: Cohort 1- 12 Month final follow-up | Number of infusions that are discontinued, slowed, or interrupted | 12 Month final follow-up |
| Infusion parameter 4.2: Cohort 2- Start of data collection | Number of infusions that are discontinued, slowed, or interrupted | Baseline |
| Infusion parameter 4.2: Cohort 2- 12 Month final follow-up | Number of infusions that are discontinued, slowed, or interrupted | 12 Month final follow-up |
| Infusion parameter 4.3: Cohort 1- Month 3 | Median number of infusions to reach participant's maximum infusion rate | Month 3 |
| Infusion parameter 4.3: Cohort 1- Month 6 | Median number of infusions to reach participant's maximum infusion rate | Month 6 |
| Infusion parameter 4.3: Cohort 1- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion rate | 12 Month final follow-up |
| Infusion parameter 4.3: Cohort 2- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion rate | 12 Month final follow-up |
| Infusion parameter 5.1: Cohort 1- Start of data collection | Mean dose | Baseline |
| Infusion parameter 5.1: Cohort 1- Month 3 | Mean dose | Month 3 |
| Infusion parameter 5.1: Cohort 1- Month 6 | Mean dose | Month 6 |
| Infusion parameter 5.1: Cohort 1- 12 Month final follow-up | Mean dose | 12 Month final follow-up |
| Infusion parameter 5.1: Cohort 2- Start of data collection | Mean dose | Baseline |
| Infusion parameter 5.1: Cohort 2- 12 Month final follow-up | Mean dose | 12 Month final follow-up |
| Infusion parameter 5.2: Cohort 1- Start of data collection | Mean dosing interval | Baseline |
| Infusion parameter 5.2: Cohort 1- Month 3 | Mean dosing interval | Month 3 |
| Infusion parameter 5.2: Cohort 1- Month 6 | Mean dosing interval | Month 6 |
| Infusion parameter 5.2: Cohort 1- 12 Month final follow-up | Mean dosing interval | 12 Month final follow-up |
| Infusion parameter 5.2: Cohort 2- Start of data collection | Mean dosing interval | Baseline |
| Infusion parameter 5.2: Cohort 2- 12 Month final follow-up | Mean dosing interval | 12 Month final follow-up |
| Infusion parameter 5.3: Cohort 1- Start of data collection | Mean number of dose adjustments | Baseline |
| Infusion parameter 5.3: Cohort 1- Month 3 | Mean number of dose adjustments | Month 3 |
| Infusion parameter 5.3: Cohort 1- Month 6 | Mean number of dose adjustments | Month 6 |
| Infusion parameter 5.3: Cohort 1- 12 Month final follow-up | Mean number of dose adjustments | 12 Month final follow-up |
| Infusion parameter 5.3: Cohort 2- Start of data collection | Mean number of dose adjustments | Baseline |
| Infusion parameter 5.3: Cohort 2- 12 Month final follow-up | Mean number of dose adjustments | 12 Month final follow-up |
| Infusion parameter 4.1: Cohort 3- 12 Month final follow-up | Median maximal infusion rate per site | 12 Month final follow-up |
| Infusion parameter 4.2: Cohort 3- 12 Month final follow-up | Number of infusions that are discontinued, slowed, or interrupted | 12 Month final follow-up |
| Infusion parameter 4.3: Cohort 3- 12 Month final follow-up | Median number of infusions to reach participant's maximum infusion rate | 12 Month final follow-up |
| Infusion parameter 5.1: Cohort 3- 12 Month final follow-up | Mean dose | 12 Month final follow-up |
| Infusion parameter 5.2: Cohort 3- 12 Month final follow-up | Mean dosing interval | 12 Month final follow-up |
| Infusion parameter 5.3: Cohort 3- 12 Month final follow-up | Mean number of dose adjustments | 12 Month final follow-up |
| Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1 | TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain. | 12 Month final follow-up |
| Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2 | TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain. | 12 Month final follow-up |
| Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 3 | TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain. | 12 Month final follow-up |
| Life Quality Index (LQI): Cohort 1 | The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs. | 12 Month final follow-up |
| Life Quality Index (LQI): Cohort 2 | The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs | 12 Month final follow-up |
| Life Quality Index (LQI): Cohort 3 | The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs | 12 Month final follow-up |
| Treatment Preference Questionnaire (TPQ): Cohort 1 | The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's reference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment. | 12 Month final follow-up |
| Treatment Preference Questionnaire (TPQ): Cohort 2 | The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment. | 12 Month final follow-up |
| Treatment Preference Questionnaire (TPQ): Cohort 3 | The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment. | 12 Month final follow-up |
| Kitchener |
| Ontario |
| N2M 5E2 |
| Canada |
| Toronto Allergists | Toronto | Ontario | M5G 1E2 | Canada |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |