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A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT01887275
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Device: medical ozone therapy with humares Drug: conventional interferon-α Phase 4

Detailed Description:
Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical Ozone Versus Conventional Interferon-α Treatment of Patients With Chronic Hepatitis B —A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Study Start Date : March 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: medical ozone therapy with humares Device: medical ozone therapy with humares
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. First month: ozone concentration: 20µg ~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.
Other Name: ozone instrument made in Germany: Humares
Active Comparator: conventional interferon-α Drug: conventional interferon-α
Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.



Primary Outcome Measures :
  1. HBV DNA [ Time Frame: up to 77 weeks ]
    To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL


Secondary Outcome Measures :
  1. HBeAg [ Time Frame: up to 77 weeks ]
    Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female;
  • HBsAg positive for over 6 months;
  • ALT over 2×ULN, TBIL less than 80 µmol/L.

Exclusion Criteria:

  • Patient has a history of hemorrhagic or hemolysis disease;
  • Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
  • Patient is co-infected with HIV or HCV;
  • Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
  • Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
  • Pregnancy;
  • Current alcohol or drug abuse;
  • Difficulty to draw blood through veins;
  • Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
  • Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
  • Patient is enrolled in any other clinical trials.

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): NCT01887275


Locations
China, Guangdong
Nanfang Hospital
GuangZhou, Guangdong, China, 510000
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: yabing guo, professor Nanfang Hospital of Southern Medical University

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01887275     History of Changes
Other Study ID Numbers: gyb61641947
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: October 2012

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic hepatitis B
Medical Ozone
Interferon-α
Efficacy

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents