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Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

Primary Purpose

Primary Immune Deficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Immunoglobulin G (Ig NextGen 16%)
Sponsored by
CSL Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Deficiency focused on measuring Primary Immune Deficiency, Subcutaneous, Immunoglobulin G

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >3 years of age.
  2. PID patients receiving Ig replacement therapy.
  3. Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration.
  4. Patient is capable of self-administering Ig NextGen 16%

Exclusion Criteria:

  1. Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
  2. Patients with known anaphylaxis reactions to immunoglobulin therapy.
  3. Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
  4. Patients with protein-losing enteropathies.
  5. Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial.
  6. Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening.
  7. Patients unwilling to comply with the protocol.

Sites / Locations

  • Campbelltown Hospital
  • Sydney Children's Hospital
  • Royal Adelaide Hospital
  • Women's & Children's Hospital
  • Frankston Hospital
  • Royal Children's Hospital
  • Auckland Hospital
  • Christchurch Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Rate, Severity and Relatedness of reported Adverse Events

Secondary Outcome Measures

To monitor patient IgG trough levels while receiving Ig NextGen 16%

Full Information

First Posted
May 16, 2008
Last Updated
June 18, 2013
Sponsor
CSL Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00680446
Brief Title
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
Official Title
An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.
Detailed Description
This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency
Keywords
Primary Immune Deficiency, Subcutaneous, Immunoglobulin G

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Immunoglobulin G (Ig NextGen 16%)
Other Intervention Name(s)
Ig NextGen 16%
Intervention Description
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
Primary Outcome Measure Information:
Title
Rate, Severity and Relatedness of reported Adverse Events
Time Frame
Up to Four Years
Secondary Outcome Measure Information:
Title
To monitor patient IgG trough levels while receiving Ig NextGen 16%
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >3 years of age. PID patients receiving Ig replacement therapy. Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration. Patient is capable of self-administering Ig NextGen 16% Exclusion Criteria: Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment. Patients with known anaphylaxis reactions to immunoglobulin therapy. Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy. Patients with protein-losing enteropathies. Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial. Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening. Patients unwilling to comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical and Research Director
Organizational Affiliation
CSL
Official's Role
Study Director
Facility Information:
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Women's & Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

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Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

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