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A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

2014-08-27 03:42:00 | BioPortfolio

Summary

This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.

Description

This is an open-label, single-sequence, multi-center trial with subjects previously diagnosed with primary immune deficiency. Subjects will be on IGIV until until a steady state is reached at which time PK profiling during the IV phase will occur. Subjects will begin SC administration 1 week following last IV dose and followed for a period of six months. PK profiling in SC phase will occur when subject reaches approximate steady-state on SC administration.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Immunologic Deficiency Syndrome

Intervention

Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified

Location

University of California, Irvine
Irvine
California
United States
92697

Status

Completed

Source

Talecris Biotherapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:00-0400

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