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

Recruiting now · Phase 2

Conditions studied: Chronic Graft-versus-host Disease

In brief

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

Key facts

Study ID

NCT02918188

Run by

Navy General Hospital, Beijing

People needed

21

Starts

2016-01-01

Expected to finish

2031-01-01

Last updated by the study team

2020-07-21

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Navy General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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