NCT03401268

Brief Summary

Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG) will also be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

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

January 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

January 5, 2018

Last Update Submit

May 7, 2019

Conditions

Hypogammaglobulinemia

Keywords

hypogammaglobulinemiaallogeneic hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Tolerability of home ScIG as replacement therapy for hypogammaglobulinemia in allogeneic transplant patients

    Qualitative survey describing tolerability, QOL assessment

    6 months

Secondary Outcomes (1)

  • Financial analysis of cost of ScIG in allogeneic HCT patients

    1 year

Study Arms (1)

Patient cohort

EXPERIMENTAL

The study population will include 24 patients, that are either already on IVIG or are eligible for ScIG as initial Ig replacement, that will undergo Ig replacement with subcutaneous immunoglobulin (ScIG) for a total of 6 months.

Drug: subcutaneous immunoglobulin

Interventions

subcutaneous immunoglobulinDRUG

24 patients demonstrating hypogammaglobulinemia post allogeneic HCT will be started on ScIG for a total of 6 months. Tolerability of the intervention will be assessed with qualitative questionnaires, as well as a financial analysis regarding the intervention.

Also known as: ScIG
Patient cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Patients at least 100 days post allogeneic hematopoietic cell transplantation for any benign or malignant hematological disease, from a related or unrelated donor
  • Patients who are already established on regular IVIG
  • Patients eligible for immunoglobulin replacement with an IgG \<7mg/L, or normal IgG total but IgG2 or IgG4 below normal
  • Patients with IgG =\>7g/L but with at least 2 prior episodes of bacterial infection (proven or suspected eg. sinusitis diagnosed on CT)
  • No other medical condition which would preclude treatment with immunoglobulin
  • Willing to participate and sign informed consent

You may not qualify if:

  • Previous serious adverse reaction from IVIG or products from Hizentra (polysorbate)
  • Other serious medical or psychiatric disorders which may interfere with the patient's ability to participate in the study, or interfere with study assessment (e.g. advanced congestive heart failure, severe liver disease, renal failure, disease relapse or secondary malignancy, schizophrenia, paranoid psychosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Pasic I, Alanazi W, Dranitsaris G, Lieberman L, Viswabandya A, Kim DDH, Lipton JH, Michelis FV. Subcutaneous immunoglobulin in allogeneic hematopoietic cell transplant patients: A prospective study of feasibility, safety, and healthcare resource use. Hematol Oncol Stem Cell Ther. 2021 Dec;14(4):302-310. doi: 10.1016/j.hemonc.2021.01.001. Epub 2021 Feb 23.

    PMID: 33684377DERIVED

MeSH Terms

Conditions

Agammaglobulinemia

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Fotios V. Michelis, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 17, 2018

Study Start

February 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

CA(1)