NCT02918188RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 21 Jul 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 27 Sept 2016
- Start date
- Jan 2016
- Primary completion date
- Jan 2026
- Lead sponsor
- Navy General Hospital, Beijing
- NCT number
- NCT02918188
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 21
- From Jan 2016 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other investigational agents administered within last four weeks
- Inability to comply with medical therapy or follow-up
Other illness
- Patients with stable disease, not well controlled by the current treatment
- HIV positive
- Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy
- Cardiac insufficiency (\>grade II, New York Heart Association classification)
Lab values
- Severe liver or renal impairment: serum creatinine \>2.5 mg/dl; serum bilirubin\>2.5 mg/dl (without evidence of hepatic cGVHD)
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: - to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Navy General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.