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Completed

NCT Number: NCT03716700

Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

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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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of McMaster, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(The participant will not be considered eligible for the study without meeting all of the criteria below):

  • Voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent or assent as applicable to participate in the study;
  • Participant > 2 years of age with a documented diagnosis of PID or SID requiring IgG replacement therapy, as defined by the International Union of Immunological Societies Scientific Committee 2009 and by diagnostic criteria according to Conley et al., 1999;
  • Participant has received subcutaneous immunoglobulin (SCIG) therapy previous to CUVITRU for at least 3 months; and
  • Participant has received CUVITRU in line with the product specification (CUVITRU Product Monograph (Baxalta Canada Corporation, 2018) at start of study

Exclusion criteria

(Participants are excluded from the study if any of the following criteria are met):

  • Participation in any interventional clinical study within the last 30 days
  • Participant participates in a clinical study in parallel during the observation period; and
  • Participant had a dose change 30 days prior to transition to CUVITRU for Cohort 1

Treatment and study plan

CUVITRU

Biological

CUVITRU

Other names: 20% Solution, IGSC, Immune Globulin Subcutaneous (Human)

Primary outcomes

  1. Infusion parameter 1: Cohort 1-Start of data collection

    Time frame: Baseline

    Median infusion volume per site

  2. Infusion parameter 1: Cohort 1- Month 3

    Time frame: Month 3

    Median infusion volume per site

  3. Infusion parameter 1: Cohort 1- Month 6

    Time frame: Month 6

    Median infusion volume per site

  4. Infusion parameter 1: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per site

  5. Infusion parameter 1: Cohort 2- Start of data collection

    Time frame: Baseline

    Median infusion volume per site

  6. Infusion parameter 1: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per site

  7. Infusion parameter 1.1: Cohort 1- Start of data collection

    Time frame: Baseline

    Median infusion volume per infusion

  8. Infusion parameter 1.1: Cohort 1- Month 3

    Time frame: Month 3

    Median infusion volume per infusion

  9. Infusion parameter 1.1: Cohort 1- Month 6

    Time frame: Month 6

    Median infusion volume per infusion

  10. Infusion parameter 1.1: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per infusion

  11. Infusion parameter 1.1: Cohort 2- Start of data collection

    Time frame: Baseline

    Median infusion volume per infusion

  12. Infusion parameter 1.1: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per infusion

  13. Infusion parameter 2: Cohort 1- Start of data collection

    Time frame: Baseline

    Median number of infusion sites

  14. Infusion parameter 2: Cohort 1- Month 3

    Time frame: Month 3

    Median number of infusion sites

  15. Infusion parameter 2: Cohort 1- Month 6

    Time frame: Month 6

    Median number of infusion sites

  16. Infusion parameter 2: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusion sites

  17. Infusion parameter 2: Cohort 2- Start of data collection

    Time frame: Baseline

    Median number of infusion sites

  18. Infusion parameter 2: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusion sites

  19. Infusion parameter 3: Cohort 1- Start of data collection

    Time frame: Baseline

    Median infusion duration

  20. Infusion parameter 3: Cohort 1- Month 3

    Time frame: Month 3

    Median infusion duration

  21. Infusion parameter 3: Cohort 1- Month 6

    Time frame: Month 6

    Median infusion duration

  22. Infusion parameter 3: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion duration

  23. Infusion parameter 3: Cohort 2- Start of data collection

    Time frame: Baseline

    Median infusion duration

  24. Infusion parameter 3: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion duration

  25. Infusion parameter 3.1: Cohort 1- Month 3 Follow-up

    Time frame: Month 3

    Median number of infusions to reach participant's maximum infusion volume

  26. Infusion parameter 3.1: Cohort 1- Month 6 Follow-up

    Time frame: Month 6

    Median number of infusions to reach participant's maximum infusion volume

  27. Infusion parameter 3.1: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume

  28. Infusion parameter 3.1: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume

  29. Infusion parameter 3.2: Cohort 1- Start of data collection

    Time frame: Baseline

    Median number of infusions per month per participant

  30. Infusion parameter 3.2: Cohort 1- Month 3

    Time frame: Month 3

    Median number of infusions per month per participant

  31. Infusion parameter 3.2: Cohort 1- Month 6

    Time frame: Month 6

    Median number of infusions per month per participant

  32. Infusion parameter 3.2: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions per month per participant

  33. Infusion parameter 3.2: Cohort 2- Start of data collection

    Time frame: Baseline

    Median number of infusions per month per participant

  34. Infusion parameter 3.2: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions per month per participant

  35. Infusion parameter 3.3: Cohort 1- Start of data collection

    Time frame: Baseline

    Median number of infusions to reach final dose interval per participant

  36. Infusion parameter 3.3: Cohort 1- Month 3

    Time frame: Month 3

    Median number of infusions to reach final dose interval per participant

  37. Infusion parameter 3.3: Cohort 1- Month 6

    Time frame: Month 6

    Median number of infusions to reach final dose interval per participant

  38. Infusion parameter 3.3: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

  39. Infusion parameter 3.3: Cohort 2- Start of data collection

    Time frame: Baseline

    Median number of infusions to reach final dose interval per participant

  40. Infusion parameter 3.3: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

  41. Infusion parameter 1: Cohort 3- 12 Month Final Follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per site.

  42. Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up

    Time frame: 12 Month final follow-up

    Median infusion volume per infusion.

  43. Infusion parameter 2: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusion sites.

  44. Infusion parameter 3: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median infusion duration.

  45. Infusion parameter 3.1: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume (infusion rate)

  46. Infusion parameter 3.2: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions per month per participant

  47. Infusion parameter 3.3: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

Secondary outcomes

  1. Infusion parameter 4.1: Cohort 1- Start of data collection

    Time frame: Baseline

    Median maximal infusion rate per site

  2. Infusion parameter 4.1: Cohort 1- Month 3

    Time frame: Month 3

    Median maximal infusion rate per site

  3. Infusion parameter 4.1: Cohort 1- Month 6

    Time frame: Month 6

    Median maximal infusion rate per site

  4. Infusion parameter 4.1: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median maximal infusion rate per site

  5. Infusion parameter 4.1: Cohort 2- Start of data collection

    Time frame: Baseline

    Median maximal infusion rate per site

  6. Infusion parameter 4.1: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median maximal infusion rate per site

  7. Infusion parameter 4.2: Cohort 1- Start of data collection

    Time frame: Baseline

    Number of infusions that are discontinued, slowed, or interrupted

  8. Infusion parameter 4.2: Cohort 1- Month 3

    Time frame: Month 3

    Number of infusions that are discontinued, slowed, or interrupted

  9. Infusion parameter 4.2: Cohort 1- Month 6

    Time frame: Month 6

    Number of infusions that are discontinued, slowed, or interrupted

  10. Infusion parameter 4.2: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Number of infusions that are discontinued, slowed, or interrupted

  11. Infusion parameter 4.2: Cohort 2- Start of data collection

    Time frame: Baseline

    Number of infusions that are discontinued, slowed, or interrupted

  12. Infusion parameter 4.2: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Number of infusions that are discontinued, slowed, or interrupted

  13. Infusion parameter 4.3: Cohort 1- Month 3

    Time frame: Month 3

    Median number of infusions to reach participant's maximum infusion rate

  14. Infusion parameter 4.3: Cohort 1- Month 6

    Time frame: Month 6

    Median number of infusions to reach participant's maximum infusion rate

  15. Infusion parameter 4.3: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion rate

  16. Infusion parameter 4.3: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion rate

  17. Infusion parameter 5.1: Cohort 1- Start of data collection

    Time frame: Baseline

    Mean dose

  18. Infusion parameter 5.1: Cohort 1- Month 3

    Time frame: Month 3

    Mean dose

  19. Infusion parameter 5.1: Cohort 1- Month 6

    Time frame: Month 6

    Mean dose

  20. Infusion parameter 5.1: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dose

  21. Infusion parameter 5.1: Cohort 2- Start of data collection

    Time frame: Baseline

    Mean dose

  22. Infusion parameter 5.1: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dose

  23. Infusion parameter 5.2: Cohort 1- Start of data collection

    Time frame: Baseline

    Mean dosing interval

  24. Infusion parameter 5.2: Cohort 1- Month 3

    Time frame: Month 3

    Mean dosing interval

  25. Infusion parameter 5.2: Cohort 1- Month 6

    Time frame: Month 6

    Mean dosing interval

  26. Infusion parameter 5.2: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dosing interval

  27. Infusion parameter 5.2: Cohort 2- Start of data collection

    Time frame: Baseline

    Mean dosing interval

  28. Infusion parameter 5.2: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dosing interval

  29. Infusion parameter 5.3: Cohort 1- Start of data collection

    Time frame: Baseline

    Mean number of dose adjustments

  30. Infusion parameter 5.3: Cohort 1- Month 3

    Time frame: Month 3

    Mean number of dose adjustments

  31. Infusion parameter 5.3: Cohort 1- Month 6

    Time frame: Month 6

    Mean number of dose adjustments

  32. Infusion parameter 5.3: Cohort 1- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean number of dose adjustments

  33. Infusion parameter 5.3: Cohort 2- Start of data collection

    Time frame: Baseline

    Mean number of dose adjustments

  34. Infusion parameter 5.3: Cohort 2- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean number of dose adjustments

  35. Infusion parameter 4.1: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median maximal infusion rate per site

  36. Infusion parameter 4.2: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Number of infusions that are discontinued, slowed, or interrupted

  37. Infusion parameter 4.3: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion rate

  38. Infusion parameter 5.1: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dose

  39. Infusion parameter 5.2: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean dosing interval

  40. Infusion parameter 5.3: Cohort 3- 12 Month final follow-up

    Time frame: 12 Month final follow-up

    Mean number of dose adjustments

  41. Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1

    Time frame: 12 Month final follow-up

    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.

  42. Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2

    Time frame: 12 Month final follow-up

    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.

  43. Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 3

    Time frame: 12 Month final follow-up

    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.

  44. Life Quality Index (LQI): Cohort 1

    Time frame: 12 Month final follow-up

    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.

  45. Life Quality Index (LQI): Cohort 2

    Time frame: 12 Month final follow-up

    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

  46. Life Quality Index (LQI): Cohort 3

    Time frame: 12 Month final follow-up

    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

  47. Treatment Preference Questionnaire (TPQ): Cohort 1

    Time frame: 12 Month final follow-up

    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.

  48. Treatment Preference Questionnaire (TPQ): Cohort 2

    Time frame: 12 Month final follow-up

    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.

  49. Treatment Preference Questionnaire (TPQ): Cohort 3

    Time frame: 12 Month final follow-up

    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.

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

  • Baxalta Innovations GmbH, now part of Shire

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2018
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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