NIPH Clinical Trials Search

UMIN ID: UMIN000001716

Registered date:19/02/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStandard primary treatment-refractory acute GVHD
Date of first enrollment2009/01/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeEffectiveness of GVHD treatment from the first dose point to 4 weeks later and others
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum6months-old
Age maximumNot applicable
GenderMale and Female
Include criteria
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


public contact
Address 2-4 Kasuga-cho, Ashiya 659-0021 Japan Japan
Telephone 0797-32-8582
Affiliation JCR pharmaceuticals Co., Ltd. Research and Development div.
scientific contact
Name Keiya Ozawa
Address 3311-1 Yakushi-ji, Shimotsuke-shi, Tochigi, 329-0498, Japan Japan
Affiliation Jichi Medical University Hospital Division of Hematology