- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887275
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
June 25, 2013 updated by: Nanfang Hospital of Southern Medical University
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
The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
439
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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GuangZhou, Guangdong, China, 510000
- Nanfang Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
|
Active Comparator: conventional 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBV DNA
Time Frame: up to 77 weeks
|
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL
|
up to 77 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBeAg
Time Frame: up to 77 weeks
|
Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.
|
up to 77 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: yabing guo, professor, Nanfang Hospital of Southern Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
June 23, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 26, 2013
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
October 1, 2012
More Information
Terms related to this study
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-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
Other Study ID Numbers
- gyb61641947
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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