drugset / Trial / NCT02728895

Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT

NCT02728895

Phase 1 Completed 24 enrolled Takeda
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the initial tolerability, safety and recommended phase 2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell transplantation \[allo-HSCT\]).

Timeline

Start
2016-06-15
Primary completion
2018-07-10
Completion
2018-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 75 mg Intravenous
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous