RecruitingPhase 2NCT02918188
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
Sponsor
Navy General Hospital, Beijing
Enrollment
21 participants
Start Date
Jan 1, 2016
Study Type
INTERVENTIONAL
Summary
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
Eligibility
Max Age: 65 Years
Inclusion Criteria6
- 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 Criteria8
- 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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Interventions
DRUGHydrogen
Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02918188