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NCT Number: NCT02918188

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

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

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location status: Recruiting

Location contact

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogen

Drug

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

Other names: Hydrogen-rich water

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2031
First posted
Sep 28, 2016
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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