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

NCT00278954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-01-24

Study results available
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Summary

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.

Conditions

  • Primary Immunodeficiency
  • Common Variable Hypogammaglobulinemia
  • X-linked Hypogammaglobulinemia
  • Hypogammaglobulinemia
  • Immunodeficiency With Hyper-IgM
  • Wiskott-Aldrich Syndrome

Interventions

BIOLOGICAL

Gammaplex (Intravenous immunoglobulin)

GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously for 12 months.

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Principal Investigators

  • Melvin Berger, MD · Rainbow Babies & Children's Hospital, Cleveland, Ohio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278954 on ClinicalTrials.gov