Health TrialsbyHealthPanel

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

ConditionChronic Graft-versus-host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 65
SponsorNavy General Hospital, Beijing

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Male

not pregnant female

patients <65 years old

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Hydrogen

    Drug

    Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: HydrogenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

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)

Time frame
12 months after date of start of Hydrogen

Secondary outcomes

1

Response Rate in each domain (RRD)

Response rate in each domain was measured in subjects that had had initial involvement in that domain

Time frame
12 months after date of start of Hydrogen

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
Apply now