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

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 - A Phase I/II study of JR-031 for acute GVHD

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001716

Enrollment

Registered

2009-02-19

Start date

2009-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Standard primary treatment-refractory acute GVHD

Interventions

*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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *GradeII-IV of acute GVHD (the guideline of JSHCT). *Standard treatment-refractory acute GVHD. *Age => 6 months

Exclusion criteria

Exclusion 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%.

Design outcomes

Primary

Measure	Time frame
Effectiveness of GVHD treatment from the first dose point to 4 weeks later and others	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026