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

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Device: medical ozone therapy with humares; Drug: conventional interferon-α

• Registration Number: NCT01887275
• Lead Sponsor: Nanfang Hospital, 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.

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 Timeline

• Study Start: 2010-03
• Status Verified: 2012-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-06-23
• Study First Submitted QC: 2013-06-25
• Last Update Submitted: 2013-06-25
• Study First Posted: 2013-06-26
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medical ozone therapy with humares	medical ozone therapy with humares	-
conventional interferon-α	conventional interferon-α	-

Primary Outcome Measures

Name	Time	Method
HBV DNA	up to 77 weeks	To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL

Secondary Outcome Measures

Name	Time	Method
HBeAg	up to 77 weeks	Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 GuangZhou, Guangdong, China