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

Sponsor

Navy General Hospital, Beijing (Other)

Overall Status

Recruiting

CT.gov ID

NCT02918188

Collaborator

(none)

Enrollment

Location

Arm

180

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

N/A

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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2031

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [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)

Secondary Outcome Measures

Response Rate in each domain (RRD) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navy General Hospital	Beijing	Beijing	China	100048

Sponsors and Collaborators

Navy General Hospital, Beijing

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liren Qian, Doctor, Navy General Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT02918188

Other Study ID Numbers:

NavyGHB-004

First Posted:

Sep 28, 2016

Last Update Posted:

Jul 21, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Graft vs Host Disease

Study Results

No Results Posted as of Jul 21, 2020