Status:
COMPLETED
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Lead Sponsor:
CSL Behring
Conditions:
Primary Immune Deficiency
Eligibility:
All Genders
2-75 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00719680
Start Date
June 1 2008
End Date
June 1 2010
Last Update
April 2 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Contact CSL Behring for facility details
Centennial, Colorado, United States, 80112
2
Contact CSL Behring for facility details
North Palm Beach, Florida, United States, 33408
3
Contact CSL Behring for facility details
Indianapolis, Indiana, United States, 46202
4
Contact CSL Behring for facility details
Dallas, Texas, United States, 75230