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Recruiting Phase 2 NCT02918188

Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD

Trial Parameters

Condition Chronic Graft-versus-host Disease
Sponsor Navy General Hospital, Beijing
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 21
Sex ALL
Min Age N/A
Max Age 65 Years
Start Date 2016-01
Completion 2026-01
Interventions
Hydrogen

Brief Summary

This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.

Eligibility Criteria

Inclusion Criteria: * Written informed consent * Male * not pregnant female * patients \<65 years old * Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper) * Patient intolerant to steroid therapy Exclusion Criteria: * Patients with stable disease, not well controlled by the current treatment * Pregnancy * HIV positive * Severe liver or renal impairment: serum creatinine \>2.5 mg/dl; serum bilirubin\>2.5 mg/dl (without evidence of hepatic cGVHD) * Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy * Any other investigational agents administered within last four weeks * Cardiac insufficiency (\>grade II, New York Heart Association classification) * Inability to comply with medical therapy or follow-up

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