Clinical trialNCT00278954CompletedPhase 3Interventional

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

SponsorBio Products LaboratoryEnrollment50Common Variable HypogammaglobulinemiaHypogammaglobulinemiaImmunodeficiency With Hyper-IgMPrimary ImmunodeficiencyWiskott-Aldrich SyndromeX-linked Hypogammaglobulinemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Melvin Berger, MD
Rainbow Babies & Children's Hospital, Cleveland, Ohio
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
Family Allergy and Asthma Center Pc
Atlanta, Georgia, United States
Rush University Medical Centre, University Consultants in Allergy & Immunology
Chicago, Illinois, United States
Childrens Hospital at Buffalo, Allergy Division
Buffalo, New York, United States
Allergy, Asthma & Immunology Clinic, P.A.
Irving, Texas, United States
Ucla Medical Centre
Irving, Texas, United States
University of Washington School of Medicine, Dept. of Pediatrics
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Gammaplex →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2006
Primary completion: 30 Nov 2007
Completion: 30 Nov 2007
Last update posted: 24 Jan 2013
Registered enrollment: 50
Registry id: NCT00278954

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.