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

NCT03677557 | Unknown Phase 4

• 1 other identifier: 2018 0388-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Primary Immunodeficiency Disease; Secondary Immunodeficiency

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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

• 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

• 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

Study Arms (1)

Cutaquig Intervention

OTHER

Participants with primary or secondary immunodeficiency disease who are currently on subcutaneous immunoglobulin treatment but have developed adverse events including allergic reaction and are willing to change the treatment product to 16.5% Cutaquig.

Drug: 16,5% Cutaquig

Interventions

16,5% Cutaquig DRUG

Participants with primary or secondary immunodefiiciney disease and who do not tolerate other immunoglobulin treatments will be asked to use 16.5% Cutaquig

Cutaquig Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnant Women

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Octapharma: collaborator

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Juthaporn Cowan, MD, PhD, FRCPC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juthaporn Cowan, MD, PhD, FRCPC

CONTACT

613-737-8899; jcowan@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: September 19, 2018
• Study Start: September 19, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CA (1)