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

NCT04354129 | Active Not Recruiting

• 1 other identifier: Pro00095620
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety of Infusion Rate

  1. The primary objective is to assess safety of cutaquig® in patients with PID or SID by rapid push at infusion volumes ranging from 15 mL/infusion site to a maximum of 60 mL/infusion site into a maximum of 4 infusion sites and 2. assess safety of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)

  6 months

• Tolerability of Infusion Rate

  1. The primary objective is to assess tolerability of cutaquig® in patients with PID or SID by rapid push at infusion volumes ranging from 15 mL/infusion site to a maximum of 60 mL/infusion site into a maximum of 4 infusion sites and 2. assess tolerability of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)

  6 months

Secondary Outcomes (1)

• Questionnaire

  6 months

Study Arms (1)

PID/SID Cutaquig Treated Patients

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

Drug: Cutaquig®

Interventions

Cutaquig® DRUG

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

Also known as: Immunoglobulin (human) subcutaneous 16.5% Solution for injection (165 mg/mL)

PID/SID Cutaquig Treated Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will observe approximately 30 adult patients with PID or SID requiring IgG replacement therapy, regardless of gender or treatment regimen. Patients will be enrolled from about 2-5 centres in Canada.

You may qualify if:

• Adult patients (≥ 18 years)
• Who have PID or SID requiring IgG replacement therapy
• For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home
• Having signed an informed consent form

Sponsors & Collaborators

• University of Alberta: lead
• Octapharma: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

At the infusion visits, blood samples will be collected for laboratory evaluation.

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Immunoglobulins; Injections, Subcutaneous; Solutions; Injections

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Preparations

Study Officials

• Bruce Ritchie, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 21, 2020
• Study Start: April 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CA (1)