A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01887275|
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : June 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Device: medical ozone therapy with humares Drug: conventional interferon-α||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||439 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2010|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
|Experimental: 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. 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 Name: ozone instrument made in Germany: Humares
|Active Comparator: conventional interferon-α||
Drug: 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.
- HBV DNA [ Time Frame: up to 77 weeks ]To demonstrate the percentage of patients achieving HBV DNA＜1000copies/mL
- HBeAg [ Time Frame: up to 77 weeks ]Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887275
|GuangZhou, Guangdong, China, 510000|
|Principal Investigator:||yabing guo, professor||Nanfang Hospital of Southern Medical University|