Efficacy and safety of a new intravenous immunoglobulin (Panzyga^® ) in chronic immune thrombocytopenia.

ABSTRACT:

Objectives

To assess the efficacy and safety of intravenous immunoglobulin (IVIG) 10% (Panzyga^® ), a novel human normal IVIG 10%, in patients with chronic immune thrombocytopenia (ITP).

Background

First-line treatment options in ITP include IVIGs.

Methods

In this prospective, open-label, non-controlled, multicentre, phase III study, patients received a daily dose of IVIG 10% (1 g kg^-1 body weight) for two consecutive days. The primary end point was clinical response rate; secondary end points included alternate response definitions, time to response, response duration, platelet counts, regression of bleeding and safety.

Results

Forty patients were enrolled (57·5% male, mean age 36·7 years); the full analysis set comprised 36 patients. A cl

SUBMITTER: Arbach O 

PROVIDER: S-EPMC6850321 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature