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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00680446 |
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Date of registration:
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16/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
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Scientific title:
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An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID). |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00680446 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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New Zealand
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Contacts
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Name:
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Medical and Research Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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CSL |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Immune Deficiency
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Intervention(s)
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Drug: Immunoglobulin G (Ig NextGen 16%)
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Primary Outcome(s)
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Rate, Severity and Relatedness of reported Adverse Events
[Time Frame: Up to Four Years]
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Secondary Outcome(s)
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To monitor patient IgG trough levels while receiving Ig NextGen 16%
[Time Frame: Up to 4 years]
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Secondary ID(s)
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CSLCT-SCIG-07-42
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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