Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
NCT ID: NCT00419341
Last Updated: 2013-01-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2006-11-30
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
NCT00719680
Phase 2/3 Study of IGSC, 20% in PIDD
NCT01218438
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
NCT01175213
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
NCT01485796
Immune Globulin Subcutaenous (Human), 20%
NCT01412385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IgPro20
Human Normal Immunoglobulin for Subcutaneous Administration (IgPro20) is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.
Human Normal Immunoglobulin for Subcutaneous Administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Human Normal Immunoglobulin for Subcutaneous Administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
* Written informed consent
Exclusion Criteria
* Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
* Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
* Known hyperprolinemia
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
* Allergic reactions to immunoglobulins or other blood products
* Known antibodies to Immunoglobulin A (IgA)
* The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
* Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
* Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
* A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times the upper normal limit (UNL)
* Creatinine concentration \> 1.5 times the UNL
* Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
2 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSL Behring
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard L. Wasserman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dallas Allergy Immunology and Medical City Children's Hospital,
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Study Site
Los Angeles, California, United States
Study Site
Los Angeles, California, United States
Study Site
Centennial, Colorado, United States
Study Site
North Palm Beach, Florida, United States
Study Site
Atlanta, Georgia, United States
Study Site
Fort Wayne, Indiana, United States
Study Site
Indianapolis, Indiana, United States
Study Site
Iowa City, Iowa, United States
Study Site
St Louis, Missouri, United States
Study Site
Newark, New Jersey, United States
Study Site
New York, New York, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, Zenker O, Orange JS. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010 Sep;30(5):734-45. doi: 10.1007/s10875-010-9423-4. Epub 2010 May 8.
Wasserman RL, Melamed I, Nelson RP Jr, Knutsen AP, Fasano MB, Stein MR, Rojavin MA, Church JA. Pharmacokinetics of subcutaneous IgPro20 in patients with primary immunodeficiency. Clin Pharmacokinet. 2011 Jun;50(6):405-14. doi: 10.2165/11587030-000000000-00000.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1458
Identifier Type: OTHER
Identifier Source: secondary_id
ZLB04_009CR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.