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

July 17, 2020 updated by: Liren Qian, Navy General Hospital, Beijing

Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Liren Qian, M.D.
  • Phone Number: +861066957676
  • Email: qlr2007@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Navy General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Hydrogen-rich water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 12 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)
12 months after date of start of Hydrogen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate in each domain (RRD)
Time Frame: 12 months after date of start of Hydrogen
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Study Chair: Liren Qian, M.D., Navy General Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 1, 2031

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NavyGHB-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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