Recruiting

Cutaquig

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03677557

Conditions

Primary Immunodeficiency Disease

Secondary Immunodeficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

16,5% Cutaquig

Study Details

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

Study ID

NCT03677557

Start date

Sep 19, 2018

Status verified date

Mar, 2020

Completion date

Aug 31, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cutaquig Intervention

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.

Interventions

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

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events per participant per study visit of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment [ Time Frame: 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 [ Time Frame: Cumulative proportion of participants who are on Cutaquig at 12 months. ]
  • Quality of Life (Patient Satisfaction) [ Time Frame: The outcome measure will be assessed through study completion, an average of 1 year ]
  • Patient satisfaction (Quality of life) [ Time Frame: The outcome measure will be assessed through study completion, an average of 1 year ]
  • Treatment associated cost [ Time Frame: The outcome measure will be assessed through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Juthaporn Cowan, MD, PhD, FRCPC

613-737-8899jcowan@toh.ca

Locations

The Ottawa Hospital, General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Andrea Trinidad

613-737-8899atrinidad@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 4, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-03-04.