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Subcutaneous Ig NextGen 16% in PID Patients

NCT00391131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-06-07

No results posted yet for this study

Summary

This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.

Conditions

  • Primary Immunodeficiency (PID)

Interventions

DRUG

IgNextGen 16%

IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12

Sponsors & Collaborators

Principal Investigators

  • Marianne Empson, Dr · Auckland City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

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 NCT00391131 on ClinicalTrials.gov