Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Completed · Phase 3
Conditions studied: Primary Immune Deficiency
In brief
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
Key facts
- Study ID
- NCT00719680
- Run by
- CSL Behring
- People needed
- 21
- Starts
- 2008-06-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2014-04-02
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
- Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
- Written informed consent
You may not qualify if…
- Ongoing serious bacterial infection at the time of screening
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
- Other significant medical conditions that could increase the risk to the patient
- Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
- A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)
- Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR (NCT00419341)
- Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
- Evidence of uncooperative attitude
- Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
- Subjects who are employees at the investigational site, relatives or spouse of the investigator
Where it is running
- Contact CSL Behring for facility details — Centennial, Colorado, United States
- Contact CSL Behring for facility details — North Palm Beach, Florida, United States
- Contact CSL Behring for facility details — Indianapolis, Indiana, United States
- Contact CSL Behring for facility details — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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