Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases
Phase of Trial: Phase III
Latest Information Update: 03 Jan 2019
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At a glance
- Drugs Immune globulin (Primary) ; Immune globulin (Primary) ; Hyaluronidase
- Indications Immunodeficiency disorders
- Focus Registrational; Therapeutic Use
- Sponsors Baxalta; Baxter Healthcare Corporation
- 07 Mar 2016 Pooled analysis of 2 trials (n=63), including this parent and its extension trial [see CTP 700265758] was presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
- 07 Mar 2016 Results (pooled analysis of NCT00814320 and NCT01175213 studies (n = 63) assessing local adverse reaction rates) presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
- 02 Dec 2015 Protocol has been amended in change of time fame of primary endpoint from 1 year to 17 months.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History