A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- HBV DNA
Study Overview
Brief Summary
The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.
Detailed Description
Total of 189 patients with compensated chronic hepatitis B will be divided equally and randomly into three arms. Patients in arm I and II treated with medical ozone therapy with different medical ozone generators, one was made in Tianyi medical instruments limited company and the other in Germany. Sixty-three patients of arm III treated with Diammonium glycyrrhizinate Capsules, common used liver protective herb drug. The term of therapy is 12 weeks. Virology response, biochemistry response and hepatitis B viral serological response will be studied at the end of 12 weeks treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, not less than 16 years old；
- •HBsAg positive for over 6 months；
- •ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。
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;
- •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.
Arms & Interventions
Medical ozone therapy with tianyi
Intervention: medical ozone therapy with tianyi (Device)
medical ozone therapy with humares
Intervention: medical ozone therapy with humares (Device)
Diammonium glycyrrhizinate Capsules
Intervention: Diammonium glycyrrhizinate Capsules (Drug)
Outcomes
Primary Outcomes
HBV DNA
Time Frame: week 12
To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL or decreased 100 times at week 12.
Secondary Outcomes
- HBeAg(week12)
Investigators
guoyabing
professor
Nanfang Hospital, Southern Medical University