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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02918188 |
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Date of registration:
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27/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
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Scientific title:
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Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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21 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02918188 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Liren Qian, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Navy General Hospital |
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Name:
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Liren Qian, M.D. |
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Address:
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Telephone:
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+861066957676 |
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Email:
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qlr2007@126.com |
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Affiliation:
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Name:
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Liren Qian, M.D. |
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Address:
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Telephone:
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+861066957676 |
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Email:
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qlr2007@126.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion 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
Exclusion Criteria:
- 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
Age minimum:
N/A
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Graft-versus-host Disease
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Intervention(s)
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Drug: Hydrogen
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Primary Outcome(s)
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Overall Response Rate (ORR)
[Time Frame: 12 months after date of start of Hydrogen]
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Secondary Outcome(s)
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Response Rate in each domain (RRD)
[Time Frame: 12 months after date of start of Hydrogen]
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Secondary ID(s)
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NavyGHB-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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