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

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ClinicalTrials.gov Identifier: NCT03716700
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Baxalta Innovations GmbH, now part of Shire
Baxalta US Inc., now part of Shire
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.

Condition or disease Intervention/treatment
Primary Immunodeficiency Diseases (PID) Biological: CUVITRU

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020


Group/Cohort Intervention/treatment
Cohort 1
Cohort 2 will include participants who transitioned to CUVITRU at the study initiation (the first CUVITRU administration is at the study start)
Biological: CUVITRU
CUVITRU
Other Names:
  • 20% Solution
  • IGSC
  • Immune Globulin Subcutaneous (Human)

Cohort 2
Cohort 2 will include participants 6 months (±2 weeks) after CUVITRU initiation.
Biological: CUVITRU
CUVITRU
Other Names:
  • 20% Solution
  • IGSC
  • Immune Globulin Subcutaneous (Human)




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  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. 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, convenience, and global satisfaction

  36. 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, convenience, and global satisfaction

  37. Life Quality Index (LSI): 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

  38. Life Quality Index (LSI): 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

  39. Treatment Preference Questionnaire: 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 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.

  40. Treatment Preference Questionnaire: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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, 2017) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716700


Contacts
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Contact: Claudia Schwarz, PhD +43 1201002476592 claudia.schwarz@shire.com
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Canada, Ontario
University of McMaster Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Penelope Ferrie       ferriep@mcmaster.ca   
Principal Investigator: Paul Keith, MD         
Grand River Allergy Recruiting
Kitchener, Ontario, Canada, N2M 5E2
Contact: Jully Kim       7kimfamily@gmail.com   
Principal Investigator: Harold Kim, MD         
Toronto Allergists Recruiting
Toronto, Ontario, Canada, M5G 1E2
Contact: Maria Shering       maria.shering@gmail.com   
Principal Investigator: Jason Lee, MD         
Sponsors and Collaborators
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire
Baxalta US Inc., now part of Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT03716700     History of Changes
Other Study ID Numbers: SHP664-402
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs