Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04354129
Other study ID # Pro00095620
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03939533 - Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases Phase 3
Recruiting NCT03266627 - Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection Phase 2
Recruiting NCT03266640 - Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) Phase 2
Completed NCT01859754 - Octagam 5% Versus Comparator Post Marketing Trial
Recruiting NCT03148028 - Immunological Characteristics of Patients With PID and IBD N/A
Active, not recruiting NCT04354818 - Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)
Completed NCT03988426 - Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases Phase 3
Completed NCT01888484 - Study of Octanorm Subcutaneous IG in Patients With PID Phase 3
Completed NCT01131858 - Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency Phase 1/Phase 2
Completed NCT03211689 - The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease N/A
Terminated NCT01883921 - Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Recruiting NCT03266653 - EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection Phase 2
Completed NCT02327351 - TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID Phase 2/Phase 3
Completed NCT03618147 - Primary Immunodeficiency in Kuwait
Recruiting NCT04197596 - Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) Phase 1/Phase 2
Recruiting NCT03422614 - Pathophysiology of Inborn Immunodeficiencies N/A
Completed NCT02888535 - Intensive Care Unit and Secondary and Primary Immune Deficiency
Recruiting NCT04232085 - Reduced Intensity BMT for Immune Dysregulatory and Bone Marrow Failure Syndromes Using Post-Transplant Cyclophosphamide Phase 2
Active, not recruiting NCT03037359 - A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
Completed NCT03069079 - Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study N/A