Hydrogen in Patients With Corticosteroid-Refractory/Dependent Chronic Graft-Versus-Host-Disease: A Single-Arm, Multicenter, Open-Label, Phase 2 Trial.
Liren Qian, Miao Liu, Jianliang Shen...
https://pubmed.ncbi.nlm.nih.gov/33324415Actively Recruiting
Phase 2
Age: 0 - 65Years
All Genders
ID02918188
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host Disease
Led by Navy General Hospital, Beijing · Updated on 2020-07-21
21
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the potential effects of hydrogen as a treatment for patients with chronic graft-versus-host disease (cGVHD) who are either steroid-refractory or steroid-dependent. This phase 2 trial aims to evaluate the clinical response rate, time until treatment failure, overall survival, and any toxic effects in these patients, addressing the need for alternative therapies in cases where steroids are not effective or tolerated. Participants in this study will receive hydrogen-rich water orally at a dose of 4 mL per kg of body weight, three times per day, with a concentration of 0.8 ppm. The treatment will be monitored over a 12-month period to assess its impact. This trial does not include a placebo or comparator group and is unblinded. During the study, researchers will track overall response rate at 12 months after starting hydrogen treatment along with response rates in various disease domains. Patients will be regularly assessed for survival, treatment failure, and any side effects. The study is sponsored by Navy General Hospital, Beijing, and participants may be involved up to 12 months from treatment start, with ongoing monitoring throughout this time.
CONDITIONS
Brief Title
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
Who Can Participate
Age: 0 - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Male or non-pregnant female
- Under 65 years old
- Diagnosed with steroid-refractory or steroid-dependent chronic graft-versus-host disease
- Intolerant to steroid therapy
You will not qualify if you...
- Patients with stable disease not well controlled by current treatment
- Pregnancy
- HIV positive
- Severe liver or kidney impairment (serum creatinine >2.5 mg/dl; serum bilirubin >2.5 mg/dl without hepatic cGVHD)
- Uncontrolled malignancies or relapse of hematopoietic malignancy
- Use of any other investigational agents within the last four weeks
- Cardiac insufficiency greater than grade II (New York Heart Association classification)
- Inability to comply with medical therapy or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 12 months
Participants receive hydrogen-rich water orally as the study treatment for their chronic graft-versus-host disease.
Trial Site Locations
Total: 1 location
1
Navy General Hospital
Beijing, Beijing Municipality, China, 100048
Actively Recruiting
Loading map...
Research Team
L
Liren Qian, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here