Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

July 1, 2020 updated by: Green Cross Corporation

Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
  • Subject is willing to comply with all requirements of protocol
  • Authorization to access personal health information

Exclusion Criteria:

  • Subject has secondary immunodeficiency
  • Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
  • Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IGIV-SN
Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)
Biological: Immunoglobulin
Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more
Other Names:
  • IGIV-SN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
13 months (12 months of treatment + 1 month of Follow-Up)
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
13 months (12 months of treatment + 1 month of Follow-Up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Incidence of Infections other than acute serious bacterial infections
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
13 months (12 months of treatment + 1 month of Follow-Up)
Safety: The frequency of all AEs that occuring during the study
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
(regardless of the casual relationship)
13 months (12 months of treatment + 1 month of Follow-Up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK Endpoint (1)
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
Plasma Concentration-Time Curve (PK Parameters of Total IgG)
13 months (12 months of treatment + 1 month of Follow-Up)
PK Endpoint (2)
Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up)
Area Under the Curve (PK Parameters of Total IgG)
13 months (12 months of treatment + 1 month of Follow-Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Investigators

  • Principal Investigator: Chaim Roifman, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2019

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

April 8, 2018

First Posted (ACTUAL)

April 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC5101F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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