This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

Summary

The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.

Timeline

Start

2016-11

Primary completion

2018-12

Completion

2018-12

Publications

• Demeter J, Hamed A, Laszlo S, Suvajdzic N, Aigner S, Borner B, Staiger C. Efficacy and safety of BT595 (10% human intravenous immunoglobulin) in adult patients with chronic immune thrombocytopenia. Transfus Med. 2023 Apr;33(2):165-173. doi: 10.1111/tme.12943. Epub 2022 Nov 30.

Drugs

Indications