Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

Summary

The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

Timeline

Start

2014-04

Primary completion

2016-08-28

Completion

2017-08-26

Outcome

Missed primary endpoint

paper There was a slightly larger effect of rapid push on treatment interference than with pump so that the primary endpoint could not be met. PMID 29855752 ↗

Publications

• Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31.

Drugs

Indications