A Phase I/II study of JR-031 for the patients of standard primary treatment-refractory acute graft-versus-host disease (acute GVHD) after hematopoietic stem cell transplantation

UMIN ID: UMIN000001716

Registered date:19/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Standard primary treatment-refractory acute GVHD
• Date of first enrollment: 2009/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): *JR-031 *First dose within 48 hours after the diagnosis and 8 divided doses for 4 weeks for the participants who was diagnosed as standard treatment refractory acute GVHD.

Outcome(s)

• Primary Outcome: Effectiveness of GVHD treatment from the first dose point to 4 weeks later and others

Key inclusion & exclusion criteria

• Age minimum: 6months-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: *Patients who had the acute GVHD therapy except standard therapy with corticosteroids. *Patients who had the hematopoietic transplantation while their malignant disease was not remitted (except for the patients who have little possibility of early relapse). *Oxygen gas saturation in rest < 94%.

Related Information

• Primary Sponsor: JCR pharmaceuticals Co.,Ltd
• Source(s) of Monetary Support: JCR pharmaceuticals Co.,Ltd