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A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)

NCT04346108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-03-22

Study results available
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Summary

In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%). This study will be in 3 parts:

Part 1: Infusions with Immunoglobulin Intravenous (IGIV) every 3 or 4 weeks for 13 weeks.

Part 2: Participants will switch to weekly subcutaneous infusions with IGSC, 20% for 24 weeks.

Part 3: A subset will receive biweekly subcutaneous infusions with IGSC, 20% for 12 weeks.

The main aim of the study is to assess base levels of Immunoglobulin globulin G (IgG) levels in the blood of the participants after weekly and biweekly treatment with IGSC, 20% (in Parts 2 and 3 of the study). Their PID will be treated by their doctor according to their doctor's usual clinical practice.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

Immune Globulin Intravenous (IGIV)

Participants will receive IGIV infusion.

BIOLOGICAL

Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)

Participants will receive IGSC, 20% SC infusion.

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2021-12-22
Completion
2021-12-22

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346108 on ClinicalTrials.gov