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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: conventional interferon-α; Device: medical ozone therapy with humares

Study type: Interventional

Funder types: Other

Identifiers

NCT01887275

gyb61641947

Details and patient eligibility

About

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

Full 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.

Enrollment: 439 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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439 participants in 2 patient groups

medical ozone therapy with humares

Experimental group

Treatment:

Device: medical ozone therapy with humares

conventional interferon-α

Active Comparator group

Treatment:

Drug: conventional interferon-α