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

Primary Immune Deficiency Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354129
• Other study ID #: Pro00095620
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: Vicki Voong, BScN
• Phone: 780 492-3980
• Email: vvoong[@]ualberta.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Neoplasm Metastasis
• Primary Immune Deficiency Disorder
• Primary Immunodeficiency Diseases
• Secondary Immune Deficiency

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Octapharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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