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drugset / Trial / NCT02245412

A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease

NCT02245412 ↗

Phase 2 Terminated 25 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.

Timeline

Start
2014-11-14
Primary completion
2017-02-27
Completion
2017-02-27

Outcome

Outcome not reported

Stopped: “Terminated early at the Sponsor's discretion, not due to safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject OLENDALIZUMAB Monoclonal antibody 10 mg/kg Intravenous
Subject OLENDALIZUMAB Monoclonal antibody 20 mg/kg Intravenous

Indications

acute graft versus host disease