Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B (EMOTCHB)

A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System

The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Device: medical ozone therapy with tianyi; Device: medical ozone therapy with humares; Drug: Diammonium glycyrrhizinate Capsules

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 Type: Interventional
• Enrollment (Anticipated): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510000
      • Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, not less than 16 years old；
2. HBsAg positive for over 6 months；
3. ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。

Exclusion Criteria:

1. Patient has a history of hemorrhagic or hemolysis disease;
2. Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
3. Patient is co-infected with HIV or HCV;
4. Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
5. Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
6. Pregnancy;
7. Current alcohol or drug abuse;
8. Difficulty to draw blood through veins;
9. Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
10. Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
11. Patient is enrolled in any other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical ozone therapy with tianyi	Device: medical ozone therapy with tianyi; Medical ozone therapy with instrument made in China Patients in this arm will receive autohemotherapy. 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.; Other Names: ozone instrument made in China: TianYi
Active Comparator: medical ozone therapy with humares	Device: medical ozone therapy with humares; Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.; Other Names: ozone instrument made in Germany: Humares
Placebo Comparator: Diammonium glycyrrhizinate Capsules	Drug: Diammonium glycyrrhizinate Capsules; Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.; Other Names: ganlixin capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA	To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBeAg	Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.	week12

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Tianyi medical instruments limited company, Ningbo, China
• Investigators: Principal Investigator: yabing guo, professor, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: chronic hepatitis B; Medical ozone therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Inflammatory Agents; Glycyrrhizic Acid
• Other Study ID Numbers: a4xr2dv8