MedTrace Logo

Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

NCT00546871 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-05-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

DRUG

Immune Globulin Intravenous (Human), 10%

Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-03
Primary Completion
2009-07-01
Completion
2009-09-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT00546871 on ClinicalTrials.gov