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This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen | Experimental | Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen | Drug | Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months after date of start of Hydrogen |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in each domain (RRD) | Response rate in each domain was measured in subjects that had had initial involvement in that domain | 12 months after date of start of Hydrogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liren Qian, M.D. | Contact | +861066957676 | qlr2007@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liren Qian, M.D. | Navy General Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Recruiting | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33324415 | Derived | Qian L, Liu M, Shen J, Cen J, Zhao D. Hydrogen in Patients With Corticosteroid-Refractory/Dependent Chronic Graft-Versus-Host-Disease: A Single-Arm, Multicenter, Open-Label, Phase 2 Trial. Front Immunol. 2020 Nov 25;11:598359. doi: 10.3389/fimmu.2020.598359. eCollection 2020. |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| D006859 | Hydrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |