CSL889_2001

• Research type

  Research Study

• Full title

  A Phase 2 / Phase 3, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Adaptive Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents with Sickle Cell Disease during Vaso-Occlusive Crisis

• IRAS ID

  1010738

• Contact name

  Dennis Kraft

• Contact email

  dennis.kraft@cslbehring.com

• Sponsor organisation

  CSL Behring LLC

• Eudract number

  2024-513440-29

• Research summary

  This study consists of two parts: phase 2 (Part A) and phase 3 (Part B). It is a multicenter study designed to evaluate the safety, effectiveness, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD, and to evaluate the safety and tolerability of CSL889 in study participants.

• REC name

  London - Central Research Ethics Committee

• REC reference

  24/LO/0846

• Date of REC Opinion

  20 Feb 2025

• REC opinion

  Further Information Favourable Opinion