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Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD

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ClinicalTrials.gov Identifier: NCT02918188
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Liren Qian, Navy General Hospital, Beijing

Brief Summary:
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.

Condition or disease Intervention/treatment Phase
Chronic Graft-versus-host Disease Drug: Hydrogen Phase 2

Detailed Description:
The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
Study Start Date : January 2016
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2031


Arm Intervention/treatment
Experimental: Hydrogen
Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm)
Drug: Hydrogen
Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
Other Name: Hydrogen-rich water




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 6 months after date of start of Hydrogen ]

    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)



Secondary Outcome Measures :
  1. Time to treatment Failure (TTF) [ Time Frame: participants will be followed for the duration of the 6 months of treatment, and for the follow-up for expected average of 12 months ]
    Time to treatment Failure

  2. Overall Survival (OS) [ Time Frame: participants will be followed for the duration of the 6 months of treatment, and for the follow-up for expected average of 12 months ]
    Overall Survival



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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918188


Contacts
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Contact: Liren Qian, M.D. +861066957676 qlr2007@126.com

Locations
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China, Beijing
Navy General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Liren Qian, M.D.    +861066957676    qlr2007@126.com   
Sponsors and Collaborators
Navy General Hospital, Beijing
Investigators
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Study Chair: Liren Qian, M.D. Navy General Hospital

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Responsible Party: Liren Qian, Doctor, Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02918188     History of Changes
Other Study ID Numbers: NavyGHB-004
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases