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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- HBV DNA
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female；
- •HBsAg positive for over 6 months；
- •ALT over 2×ULN, TBIL less than 80 µmol/L.
排除标准
- •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.
研究组 & 干预措施
medical ozone therapy with humares
干预措施: medical ozone therapy with humares (Device)
conventional interferon-α
干预措施: conventional interferon-α (Drug)
结局指标
主要结局
HBV DNA
时间窗: up to 77 weeks
To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL
次要结局
- HBeAg(up to 77 weeks)