drugset / Trial / NCT02032095

The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

NCT02032095 ↗

Phase 2/3 Completed 17 enrolled Japan Blood Products Organization
NaSingle-groupOpen-labelTreatment

Summary

It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.

Timeline

Start
2013-11
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GB-0998 Protein / enzyme biologic 1 g/kg Intravenous