MedTrace Logo

Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

NCT00680446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-06-19

No results posted yet for this study

Summary

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

Conditions

  • Primary Immune Deficiency

Interventions

DRUG

Immunoglobulin G (Ig NextGen 16%)

Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

Sponsors & Collaborators

Principal Investigators

  • Medical and Research Director · CSL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

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 NCT00680446 on ClinicalTrials.gov