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Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.

NCT04354129 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-05-08

No results posted yet for this study

Summary

This study will assess the relative safety, tolerability, and participant satisfaction in participants using the rapid manual push method with Cutaquig®. The hypothesis being that treatment with Cutaquig® by rapid manual push method will improve the safety, tolerability and patient satisfaction of participants with PID or SID.

Cutaquig® by rapid push is already approved in Canada and has proven to be efficacious in preventing significant infection. However, relative safety, tolerability, and patient satisfaction have not been studied in these patients. The information gained from this study will improve the safety and tolerability knowledge database and will support the optimal use of Cutaquig® - thus benefitting both physicians and patients.

Conditions

  • Primary Immune Deficiency Disorder
  • Secondary Immune Deficiency

Interventions

DRUG

Cutaquig®

Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.

Sponsors & Collaborators

  • Octapharma

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Bruce Ritchie, MD · University of Alberta

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04354129 on ClinicalTrials.gov