Randomized phase 2 trial of Intravenous Gamma Globulin (IVIG) for the treatment of acute vaso-occlusive crisis in patients with sickle cell disease: Lessons learned from the midpoint analysis

Complement Ther Med. 2020 Aug:52:102481. doi: 10.1016/j.ctim.2020.102481. Epub 2020 Jun 9.

Abstract

Sickle Cell Disease (SCD) is a chronic hemolytic disorder associated with frequent pain episodes, end organ damage and a shortened lifespan. Currently there exist no disease specific targeted therapies for the treatment of acute vaso-occlusive crisis (VOC) and management with analgesics and hydration is purely supportive. Improvement in understanding of disease pathophysiology has resulted in a great interest in disease modifying novel therapies and many are being evaluated in clinical trials. Here we report the results from the pre-specified mid-point analysis of the Phase 2 study of Intravenous Gamma Globulin (IVIG) for the treatment of acute VOC in patients with SCD and lessons learned.

Keywords: IVIG; Immune globulin; Sickle.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Anemia, Sickle Cell / complications
  • Anemia, Sickle Cell / drug therapy*
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulins, Intravenous / therapeutic use*
  • Immunologic Factors / therapeutic use
  • Male
  • Pain Management / methods*
  • Young Adult
  • gamma-Globulins / therapeutic use*

Substances

  • Immunoglobulins, Intravenous
  • Immunologic Factors
  • gamma-Globulins