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New treatment option for Chronic Graft-versus-host Disease
Official title Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
ClinicalTrials.gov ID: NCT02918188
What this study is testing
What is Hydrogen?
Hydrogen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic graft-versus-host disease.
Also referred to as Hydrogen-rich water.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 65
You may be able to join 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...
You likely can't join 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...
- Any other investigational agents administered within last four weeks
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.