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

Baxalta

Status

Completed

Conditions

Primary Immunodeficiency Diseases (PID)

Treatments

Biological: CUVITRU

Study type

Observational

Funder types

Industry

Identifiers

SHP664-402

Details and patient eligibility

About

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

Enrollment

126 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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, 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