on-interventional study on the usage and outcomes of CUVITRU in patients with Primary Immunodeficiency Diseases

• Conditions: D80.3; Selective deficiency of immunoglobulin G [IgG] subclasses

• Registration Number: DRKS00014562
• Lead Sponsor: GWT-TUD GmbH, Abteilung Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Study Completion: 2021-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patient with a documented diagnosis of a form of primary humoral immunodeficiency (PID) involving a defect in antibody formation and requiring gammaglobulin replacement
2. Subject has received any SCIG (subcutaneous immunoglobulin) product previous to CUVITRU for at least 3 month at a stable dose
3. Subject has received CUVITRU in line with the product specification (labelling) at the time of first documentation and is expected to continue treatment with this therapy in future
4. Subject or legally authorized representative has provided written informed consent
5. Subject is likely and willing to be available for follow-up documentation including patient-reported assessments

Exclusion Criteria

1. Subject has experienced a dose change during 3 month previous to the time of CUVITRU initiation
2. Subject participates in a clinical study in parallel during the observation period

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum rate of CUVITRU infusion at 6 and 12 months.