NCT03716700

Brief Summary

This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2020

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

August 31, 2018

Last Update Submit

March 3, 2021

Conditions

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (47)

  • Infusion parameter 1: Cohort 1-Start of data collection

    Median infusion volume per site

    Baseline

  • Infusion parameter 1: Cohort 1- Month 3

    Median infusion volume per site

    Month 3

  • Infusion parameter 1: Cohort 1- Month 6

    Median infusion volume per site

    Month 6

  • Infusion parameter 1: Cohort 1- 12 Month final follow-up

    Median infusion volume per site

    12 Month final follow-up

  • Infusion parameter 1: Cohort 2- Start of data collection

    Median infusion volume per site

    Baseline

  • Infusion parameter 1: Cohort 2- 12 Month final follow-up

    Median infusion volume per site

    12 Month final follow-up

  • Infusion parameter 1.1: Cohort 1- Start of data collection

    Median infusion volume per infusion

    Baseline

  • Infusion parameter 1.1: Cohort 1- Month 3

    Median infusion volume per infusion

    Month 3

  • Infusion parameter 1.1: Cohort 1- Month 6

    Median infusion volume per infusion

    Month 6

  • Infusion parameter 1.1: Cohort 1- 12 Month final follow-up

    Median infusion volume per infusion

    12 Month final follow-up

  • Infusion parameter 1.1: Cohort 2- Start of data collection

    Median infusion volume per infusion

    Baseline

  • Infusion parameter 1.1: Cohort 2- 12 Month final follow-up

    Median infusion volume per infusion

    12 Month final follow-up

  • Infusion parameter 2: Cohort 1- Start of data collection

    Median number of infusion sites

    Baseline

  • Infusion parameter 2: Cohort 1- Month 3

    Median number of infusion sites

    Month 3

  • Infusion parameter 2: Cohort 1- Month 6

    Median number of infusion sites

    Month 6

  • Infusion parameter 2: Cohort 1- 12 Month final follow-up

    Median number of infusion sites

    12 Month final follow-up

  • Infusion parameter 2: Cohort 2- Start of data collection

    Median number of infusion sites

    Baseline

  • Infusion parameter 2: Cohort 2- 12 Month final follow-up

    Median number of infusion sites

    12 Month final follow-up

  • Infusion parameter 3: Cohort 1- Start of data collection

    Median infusion duration

    Baseline

  • Infusion parameter 3: Cohort 1- Month 3

    Median infusion duration

    Month 3

  • Infusion parameter 3: Cohort 1- Month 6

    Median infusion duration

    Month 6

  • Infusion parameter 3: Cohort 1- 12 Month final follow-up

    Median infusion duration

    12 Month final follow-up

  • Infusion parameter 3: Cohort 2- Start of data collection

    Median infusion duration

    Baseline

  • Infusion parameter 3: Cohort 2- 12 Month final follow-up

    Median infusion duration

    12 Month final follow-up

  • Infusion parameter 3.1: Cohort 1- Month 3 Follow-up

    Median number of infusions to reach participant's maximum infusion volume

    Month 3

  • Infusion parameter 3.1: Cohort 1- Month 6 Follow-up

    Median number of infusions to reach participant's maximum infusion volume

    Month 6

  • Infusion parameter 3.1: Cohort 1- 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume

    12 Month final follow-up

  • Infusion parameter 3.1: Cohort 2- 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume

    12 Month final follow-up

  • Infusion parameter 3.2: Cohort 1- Start of data collection

    Median number of infusions per month per participant

    Baseline

  • Infusion parameter 3.2: Cohort 1- Month 3

    Median number of infusions per month per participant

    Month 3

  • Infusion parameter 3.2: Cohort 1- Month 6

    Median number of infusions per month per participant

    Month 6

  • Infusion parameter 3.2: Cohort 1- 12 Month final follow-up

    Median number of infusions per month per participant

    12 Month final follow-up

  • Infusion parameter 3.2: Cohort 2- Start of data collection

    Median number of infusions per month per participant

    Baseline

  • Infusion parameter 3.2: Cohort 2- 12 Month final follow-up

    Median number of infusions per month per participant

    12 Month final follow-up

  • Infusion parameter 3.3: Cohort 1- Start of data collection

    Median number of infusions to reach final dose interval per participant

    Baseline

  • Infusion parameter 3.3: Cohort 1- Month 3

    Median number of infusions to reach final dose interval per participant

    Month 3

  • Infusion parameter 3.3: Cohort 1- Month 6

    Median number of infusions to reach final dose interval per participant

    Month 6

  • Infusion parameter 3.3: Cohort 1- 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

    12 Month final follow-up

  • Infusion parameter 3.3: Cohort 2- Start of data collection

    Median number of infusions to reach final dose interval per participant

    Baseline

  • Infusion parameter 3.3: Cohort 2- 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

    12 Month final follow-up

  • Infusion parameter 1: Cohort 3- 12 Month Final Follow-up

    Median infusion volume per site.

    12 Month final follow-up

  • Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up

    Median infusion volume per infusion.

    12 Month final follow-up

  • Infusion parameter 2: Cohort 3- 12 Month final follow-up

    Median number of infusion sites.

    12 Month final follow-up

  • Infusion parameter 3: Cohort 3- 12 Month final follow-up

    Median infusion duration.

    12 Month final follow-up

  • Infusion parameter 3.1: Cohort 3- 12 Month final follow-up

    Median number of infusions to reach participant's maximum infusion volume (infusion rate)

    12 Month final follow-up

  • Infusion parameter 3.2: Cohort 3- 12 Month final follow-up

    Median number of infusions per month per participant

    12 Month final follow-up

  • Infusion parameter 3.3: Cohort 3- 12 Month final follow-up

    Median number of infusions to reach final dose interval per participant

    12 Month final follow-up

Secondary Outcomes (49)

  • Infusion parameter 4.1: Cohort 1- Start of data collection

    Baseline

  • Infusion parameter 4.1: Cohort 1- Month 3

    Month 3

  • Infusion parameter 4.1: Cohort 1- Month 6

    Month 6

  • Infusion parameter 4.1: Cohort 1- 12 Month final follow-up

    12 Month final follow-up

  • Infusion parameter 4.1: Cohort 2- Start of data collection

    Baseline

  • +44 more secondary outcomes

Study Arms (3)

Cohort 1

Cohort1 will include the participants who have been transitioned to CUVITRU at the time of enrollment in the study.

Biological: CUVITRU

Cohort 2

Cohort 2 will include participants 6 months (±2 weeks) after CUVITRU initiation.

Biological: CUVITRU

Cohort 3

Cohort 3 will include participants 12 months (-1 or +2 months) after CUVITRU initiation.

Biological: CUVITRU

Interventions

CUVITRUBIOLOGICAL

CUVITRU

Also known as: 20% Solution, IGSC, Immune Globulin Subcutaneous (Human)
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data will be collected on approximately 500 participants with primary immunodeficiency (PID) and secondary immunodeficiency (SID) requiring Immunoglobulin G (IgG) replacement therapy across 8-10 sites in Canada (excluding Quebec). Any specific number of participants in each cohort is not a requirement.

You may qualify if:

  • Voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent or assent as applicable to participate in the study;
  • Participant \> 2 years of age with a documented diagnosis of PID or SID requiring IgG replacement therapy, as defined by the International Union of Immunological Societies Scientific Committee 2009 and by diagnostic criteria according to Conley et al., 1999;
  • Participant has received subcutaneous immunoglobulin (SCIG) therapy previous to CUVITRU for at least 3 months; and
  • Participant has received CUVITRU in line with the product specification (CUVITRU Product Monograph (Baxalta Canada Corporation, 2018) at start of study

You may not qualify if:

  • Participation in any interventional clinical study within the last 30 days
  • Participant participates in a clinical study in parallel during the observation period; and
  • Participant had a dose change 30 days prior to transition to CUVITRU for Cohort 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of McMaster

Hamilton, Ontario, L8S 4L8, Canada

Location

Grand River Allergy

Kitchener, Ontario, N2M 5E2, Canada

Location

Toronto Allergists

Toronto, Ontario, M5G 1E2, Canada

Location

Related Publications (1)

  • Keith PK, Cowan J, Kanani A, Kim H, Lacuesta G, Lee JK, Chen J, Park M, Gladiator A. Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. Allergy Asthma Clin Immunol. 2022 Aug 7;18(1):70. doi: 10.1186/s13223-022-00709-8.

    PMID: 35934726DERIVED

Related Links

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

HizentraSolutionsgamma-Globulins

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Study Director

    Shire

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

October 23, 2018

Study Start

September 24, 2018

Primary Completion

July 23, 2020

Study Completion

July 23, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

CA(3)