Trial intelligence / Profile preview

Valproic Acid With Methylprednisolone for Acute GVHD

NCT02848105Phase 2

Key facts

Status
Unknown
Start
Jul 2016
Primary completion
Jul 2019
Countries
1
Sponsor
Shanghai Jiao Tong University School of Medicine
Modality
Small Molecules
Conditions
Acute Graft-Versus-Host Disease (aGvHD)
01

Overview

Phase 2, open-label, single-arm trial of valproic acid in Acute Graft-Versus-Host Disease (aGvHD), sponsored by Shanghai Jiao Tong University School of Medicine. Primary endpoint: Complete Response at 28 days. Status: unknown.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • VPA+Methyl

    Valproic acid added to standard methylprednisolone

03

Who it enrols

Patients with Grade II-IV aGVHD after allogeneic stem cell transplantation, without severe organ dysfunction or active severe infection.

04

Endpoints

Primary

  • Complete Response

Secondary

  • Overall Response

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