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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887275
• Other study ID #: gyb61641947
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2013
• Last updated: June 25, 2013
• Start date: March 2010
• Est. completion date: February 2013

Study information

• Verified date: October 2012
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Device:
• medical ozone therapy with humares
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.

Drug:
• conventional interferon-a
Patients in the conventional interferon-a treatment group received subcutaneouslly injection of 5 million units of conventional interferon-a in three times per week for at least 24 weeks.

Locations

Country	Name	City	State
China	Nanfang Hospital	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA	To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL	up to 77 weeks	No
Secondary	HBeAg	Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.	up to 77 weeks	No