Chronic Hepatitis B
Conditions
Keywords
Chronic hepatitis B, Medical Ozone, Interferon-α, Efficacy
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.
Interventions
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.
DRUGconventional 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA | up to 77 weeks | To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBeAg | up to 77 weeks | Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline. |
Countries
China
Outcome results
None listed