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

NCT02918188 | Recruiting Phase 2

• 1 other identifier: NavyGHB-004
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Graft-versus-host Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Response Rate in each domain (RRD)

  12 months after date of start of Hydrogen

Study Arms (1)

Hydrogen

EXPERIMENTAL

Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm)

Drug: Hydrogen

Interventions

Hydrogen DRUG

Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)

Also known as: Hydrogen-rich water

Hydrogen

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33324415 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• Liren Qian, M.D.

  Navy General Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Liren Qian, M.D.

CONTACT

+861066957676; qlr2007@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)