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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Device: medical ozone therapy with humares
* Drug: conventional interferon-α


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical ozone therapy with humares<br> | Device: medical ozone therapy with humares<br>* 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.<br>* Other names: ozone instrument made in Germany: Humares;|
| Active Comparator: conventional interferon-α<br> | Drug: conventional interferon-α<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA | To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL | up to 77 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg | Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline. | up to 77 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, Medical Ozone, Interferon-α, Efficacy