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Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

NCT02848105 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-08-01

No results posted yet for this study

Summary

aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1\~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

Conditions

  • Peripheral Blood Stem Cell Transplantation
  • aGVHD

Interventions

DRUG

VPA

Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiong HU, M.D., · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848105 on ClinicalTrials.gov