Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment

Primary Immunodeficiency Disease Clinical Trial

Official title:

Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment in Patients Who Did Not Tolerate Other 20% Subcutaneous Immunoglobulin Product(s)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03677557
• Other study ID #: 2018 0388-01H
• Status: Recruiting
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: Juthaporn Cowan, MD, PhD, FRCPC
• Phone: 613-737-8899
• Email: jcowan[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with primary or secondary immunodeficiency disease who have developed adverse reactions to products available on the market such as Cuvitru® (Shire), Hizentra® (CSL Behring) or 10% Gammunex® (Grifols), may benefit from utilizing 16.5% Cutaquig® (Octapharma).

Description:

This is a prospective interventional study before and after clinically driven change in treatment formulation.

Polyvalent immunoglobulin treatment is used in patients with primary or secondary antibody deficiency diseases to prevent and lower the risk of infection. There are multiple products available in the market. Most products are administered via intravenous route such as Privigen® (CSL Behring), Gammunex® (Grifols), and Panzyga® (Octapharma). Up until recently, there have been only two products that are licensed for subcutaneous administration - 20% Hizentra® (CSL Behring) and 10% Gammunex® (Grifols).

In our clinical experience, approximately 10% of patients treated with 20% Hizentra® developed adverse reactions. Some are mild and tolerable. Some are moderate to severe and required alteration of treatment plan: For example, changing the product from 20% Hizentra® to 10% Gammunex®. However, this results in a 100% increase in the injection volume due to the lesser concentration of the product, but a decrease in viscosity - both of which might alter overall tolerance. Likewise, any new treatment may bring new adverse events such as rash.

In 2018, there will be two additional subcutaneous immunoglobulin products available in Canada - 16.5% Cutaquig® (Octapharma) and 20% Cuvitru® (Shire).

Even though both new products are licensed and proven to be efficacious regarding preventing significant infection (1,2), the relative safety, tolerability, patient satisfaction, treatment-associated cost has not been studied in patients using the 16.5% Cutaquig®. The study product will be provided through the Canadian Blood Service (CBS) on a special request basis which is a standard procedure for any patients who are intolerable to inventory products.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years and older

• Patients with primary or secondary immunodeficiency disease who are currently on subcutaneous immunoglobulin treatment but have developed adverse events and are willing to change the treatment product.

Exclusion Criteria:

• Pregnant Women

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Disease
• Secondary Immunodeficiency

Intervention

Drug:
• 16,5% Cutaquig
Participants with primary or secondary immunodefiiciney disease and who do not tolerate other immunoglobulin treatments will be asked to use 16.5% Cutaquig

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Octapharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events per participant per study visit of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment	The safety will be measured by the number of adverse events per participant per study visit	The outcome measure will be assessed through study completion, an average of 1 year
Primary	Retention of participants who are able to tolerate the study intervention at 12 months	Retention of participants who are able to tolerate the study intervention will be calculated as the number of participants enrolled between the 6 and 12 month visits	Cumulative proportion of participants who are on Cutaquig at 12 months.
Primary	Quality of Life (Patient Satisfaction)	This will be measured by quality of life questionnaire (SF-36) before and after change in treatment at 6 and 12 months	The outcome measure will be assessed through study completion, an average of 1 year
Primary	Patient satisfaction (Quality of life)	This will be measured by quality of life questionnaire (Euroquol 5D-5L) before and after change in treatment at 6 and 12 months	The outcome measure will be assessed through study completion, an average of 1 year
Primary	Treatment associated cost	This will measure the cost of nursing time and will be reported as dollars/patient/year	The outcome measure will be assessed through study completion, an average of 1 year