Chronic Hepatitis BPhase 3EMOTCHBNCT01342185
Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B
A Phase 3 study testing medical ozone therapy with tianyi, medical ozone therapy with humares and Diammonium glycyrrhizinate Capsules in people with Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- medical ozone therapy with tianyi, medical ozone therapy with humares and Diammonium glycyrrhizinate Capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, not less than 16 years old；
- HBsAg positive for over 6 months；
- ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- medical ozone therapy with tianyi, medical ozone therapy with humares, Diammonium glycyrrhizinate Capsules
- Keywords
- Medical ozone therapy, chronic hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical ozone therapy with tianyiDevice
Also called ozone instrument made in China: 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.
medical ozone therapy with humaresDevice
Also called ozone instrument made in Germany: Humares
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.
Diammonium glycyrrhizinate CapsulesDrug
Also called ganlixin capsules
Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Medical ozone therapy with tianyi | Experimental | Not described Receives: Device: medical ozone therapy with tianyi |
| medical ozone therapy with humares | Active comparator | Not described Receives: Device: medical ozone therapy with humares |
| Diammonium glycyrrhizinate Capsules | Placebo comparator | Not described Receives: Drug: Diammonium glycyrrhizinate Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
Measured: week 12
Secondary outcomes (1)
HBeAg
Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
Measured: week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianyi medical instruments limited company, Ningbo, China
- Responsible party
- Principal investigator, guoyabing, Nanfang Hospital, Southern Medical University
- Investigators
- yabing guo, professor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342185
- Sponsor's protocol ID
- a4xr2dv8
- Acronym
- EMOTCHB
- Status last verified
- Oct 2012
- First submitted
- 16 Feb 2011
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System
- ClinicalTrials.gov ID
- NCT01342185
- Acronym / sponsor ID
- EMOTCHB / a4xr2dv8
- Conditions
- Chronic Hepatitis B
- Keywords
- Medical ozone therapy, chronic hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Tianyi medical instruments limited company, Ningbo, China
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical ozone therapy with tianyi | Experimental | Device: medical ozone therapy with tianyi |
| medical ozone therapy with humares | Active comparator | Device: medical ozone therapy with humares |
| Diammonium glycyrrhizinate Capsules | Placebo comparator | Drug: Diammonium glycyrrhizinate Capsules |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, not less than 16 years old；
- HBsAg positive for over 6 months；
- ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical ozone therapy with tianyiAlso: ozone instrument made in China: TianYiMedical 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. | Device | Medical ozone therapy with tianyi |
| medical ozone therapy with humaresAlso: ozone instrument made in Germany: HumaresMedical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ. | Device | medical ozone therapy with humares |
| Diammonium glycyrrhizinate CapsulesAlso: ganlixin capsulesDrug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks. | Drug | Diammonium glycyrrhizinate Capsules |
Primary outcome
HBV DNA
Time frame: week 12
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
1 secondary outcome
HBeAg
Time frame: week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yabing guo, professor principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing medical ozone therapy with tianyi, medical ozone therapy with humares and Diammonium glycyrrhizinate Capsules in people with Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.