Hydrogen: Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
Study summary
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
Eligibility
Sex
ALL
Min age
—
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Overall Response Rate (ORR) — 12 months after date of start of Hydrogen Overall Response Rate (ORR) is defined as an Objective improvement at sixth month, and includes at least 1 of the following criteria:
At least 50% reduction of body surface area involved; Reduction (at least 20%) of skin sclerosis, measured by Rodnan score Improvement\>1 point in functional pulmonary tests, evaluated by LFS score; \>50% steroid reduction (for at least 4 weeks)
Trial sites (1)
Facility
City
Region
Status
Navy General Hospital
Beijing
Beijing Municipality
Recruiting
More Navy General Hospital, Beijing trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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