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Clinical Trials in China / NCT02918188
Recruiting Phase 2

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

NCT02918188 · tracked via the Priya Life Science China tracker
Sponsor
Navy General Hospital, Beijing
Phase
Phase 2
Started
2016-01
Last updated
2020-07-21

Condition(s) studied

Chronic Graft-versus-host Disease

Investigational drug(s) / intervention(s)

Hydrogen

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)

Trial sites (1)

FacilityCityRegionStatus
Navy General Hospital Beijing Beijing Municipality Recruiting

More Navy General Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

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.

View NCT02918188 on ClinicalTrials.gov ↗ ← All trials in China