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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-24

Study Completion Date

2020-07-23

Brief Summary

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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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Detailed Description

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Conditions

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Primary Immunodeficiency Diseases (PID)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Cohort1 will include the participants who have been transitioned to CUVITRU at the time of enrollment in the study.

CUVITRU

Intervention Type BIOLOGICAL

CUVITRU

Cohort 2

Cohort 2 will include participants 6 months (±2 weeks) after CUVITRU initiation.

CUVITRU

Intervention Type BIOLOGICAL

CUVITRU

Cohort 3

Cohort 3 will include participants 12 months (-1 or +2 months) after CUVITRU initiation.

CUVITRU

Intervention Type BIOLOGICAL

CUVITRU

Interventions

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CUVITRU

Intervention Type BIOLOGICAL

Other Intervention Names

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20% Solution IGSC Immune Globulin Subcutaneous (Human)

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No