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

Safety, Tolerability, and Patient Satisfaction of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment by Rapid Push in Patients With Primary or Secondary Immunodeficiency (PID or SID)

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Immune Deficiency Disorder; Secondary Immune Deficiency
• Intervention / Treatment: Drug: Cutaquig®

Detailed Description

Primary and secondary immunodeficiency diseases (PID and SID, respectively) affect the development and/or function of the immune system, resulting in increased frequency of infection. Treatment of these disorders using Cutaquig® (a subcutaneous immunoglobulin infusion (SCIG)) was licensed in Canada in 2018 and has proven to be effective in preventing significant infection. Other brands of SCIG can be given by the participant using a syringe (called rapid manual push method), which shows the same efficacy as administration by a programmable pump. The rapid manual push method has the potential to improve quality of life, reduce infusion time, and reduce the cost of administration. This study will evaluate the safety, tolerability, and patient satisfaction of Cutaquig® by the rapid manual push method in participants with PID or SID. It will also compare the efficacy of Cutaquig with prior SCIG treatment, if applicable, in participants with PID or SID.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Vicki Voong, BScN; Phone Number: 780 492-3980; Email: vvoong@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Recruiting
      • University of Alberta
      • Contact: Bruce Ritchie, MD; Phone Number: 780-492-3550; Email: bruce.ritchie@ualberta.ca
      • Principal Investigator: Bruce Ritchie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-Patients currently participating in another interventional study at the time of inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PID/SID Cutaquig Treated Patients; Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.	Drug: Cutaquig®; Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.; Other Names: Immunoglobulin (human) subcutaneous 16.5% Solution for injection (165 mg/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Infusion Rate	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; assess safety of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)	6 months
Tolerability of Infusion Rate	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; assess tolerability of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Key secondary objectives are to assess by a questionnaire; time to infuse cutaquig®; total volume infused per infusion site; total volume infused per infusion; frequency of infusion; number of injection sites; ease of infusion (injectability) Other secondary objectives are to; assess patient quality of life (QoL) and patient satisfaction by using the EQ-5D-5L (descriptive system compromises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and depression).; compare the injectability of cutaquig® with prior SCIG administration if applicable	6 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Octapharma
• Investigators: Principal Investigator: Bruce Ritchie, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms; Genetic Diseases, Inborn; Neoplastic Processes; Neoplasm Metastasis; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins
• Other Study ID Numbers: Pro00095620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No