Back to resultsA Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
medical ozone therapy with humares
conventional interferon-α
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B, Medical Ozone, Interferon-α, Efficacy
Eligibility Criteria
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.
Sites / Locations
- Nanfang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
medical ozone therapy with humares
conventional interferon-α
Arm Description
Outcomes
Primary Outcome Measures
HBV DNA
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL
Secondary Outcome Measures
HBeAg
Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.
Full Information
NCT ID
NCT01887275
First Posted
June 23, 2013
Last Updated
June 25, 2013
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01887275
Brief Title
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic hepatitis B, Medical Ozone, Interferon-α, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medical ozone therapy with humares
Arm Type
Experimental
Arm Title
conventional interferon-α
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
medical ozone therapy with humares
Other Intervention Name(s)
ozone instrument made in Germany: Humares
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
conventional interferon-α
Intervention Description
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.
Primary Outcome Measure Information:
Title
HBV DNA
Description
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL
Time Frame
up to 77 weeks
Secondary Outcome Measure Information:
Title
HBeAg
Description
Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.
Time Frame
up to 77 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yabing guo, professor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
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