CHRONIC HEPATITIS BHBVNCT01198860
Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B
A study testing CTH Chronic Hepatitis B in people with CHRONIC HEPATITIS B, run by Nguyen Thi Trieu, MD at 2 sites in 2 countries.
Trial summary
Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. Has stronger effect on immune system, effective good against HBV replication. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- CHRONIC HEPATITIS B
- What is being tested?
- CTH Chronic Hepatitis B
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females ≥ 18 years of age with chronic and acute hepatitis B.
- Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months prior to entry.
- Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.
- Patients having treated or untreated
- Patients with compensated liver function (Child-Pugh score ≤ 6).
- Informed writted consent.
Who cannot join
- Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months prior to study screening.
- Organ or bone marrow transplant recipients.
- Evidence of active liver disease to operate.
- Received immunoglobulins, interferon or other immune e to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
- Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
- Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events.
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- Hepatocellular carcinoma.
- Serious concurrent medical illness other than hepatitis B.
- History of hypersensitivity to nucleoside analogues.
- Women of childbearing potential not practising adequate contraception.
- Pregnancy or lactation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Saigon Biopharma LLC
Wilmington, Delaware, 19801-6601
Vietnam1 site
Saigon Biopharma Company Limited
Hồ Chí Minh, Ho Chi Minh City, 700000
About this study
Official title: Tenofovir Disoproxil Fumarat - Phyllanthus Urinaria- Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.
Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments.
Has stronger effect on immune system, effective good against HBV replication. This is a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.
Read the detailed description
Recent studies have proved Phyllanthus Urinaria - Adenosmatis Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. To made a clean jobs for HBV - DNA in the patient's body - hope this is a new step of medicine, will no longer exist phrase "chronic HBV infection " Methods of safety, therapeutic effect on expected cost savings should easily apply to everyone everywhere in the world. According to the investigation and must be called , Chronic HBV infection is an important worldwide cause of morbidity, mortality and source of potential new infections. There are an estimated 350 million carriers of HBV in the world. In China, Southeast Asia and sub-Saharan Africa, as many as 10-15% of the population are chronically infected. In North America and Northern Europe, infection and carrier rates are much lower, usually below 1%. Intermediate carrier rates of 1-5% are found in Southern Europe (e.g., Italy, Greece and Spain), parts of South and Central America, the Middle East and Japan. Persistent infection develops in over 90% of perinatally infected children and in 3-10% of people who become infected after the age of 6 years. Worldwide, it has been estimated that more than one million people die annually due to HBV-related end stage diseases such as cirrhosis and hepatocellular carcinoma.
The goal of antiviral therapy for hepatitis B is to reduce a patient's risks for progressive liver disease through prolonged suppression and eradication of HBV infection and to arrest or ameliorate HBV-related liver damage.
- Conditions
- CHRONIC HEPATITIS B
- Being tested
- CTH Chronic Hepatitis B
- Keywords
- HBsAg
- 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.
CTH Chronic Hepatitis BDrug
Also called - Ascorbic Acid, - Phyllanthus Urinaria, - Adenosma Glutinosum, - Eclipta Prostrata
Drug:
- Tenofovir
- Phyllanthus Urinaria
- Adenosma Glutinosum
- Eclipta Prostrata
- Ascorbic Acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (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.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Nguyen Thi Trieu, MD
- Responsible party
- Sponsor-investigator, Nguyen Thi Trieu, MD, Trieu, Nguyen Thi, M.D.
- Investigators
- Nguyễn Thị Triệu, Dr., Study director, Tran Minh Duc, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198860
- Sponsor's protocol ID
- HBsAg 07-10 - Private Clinic
- Acronym
- HBV
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2010
- Last updated
- 15 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir Disoproxil Fumarat - Phyllanthus Urinaria- Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.
- ClinicalTrials.gov ID
- NCT01198860
- Acronym / sponsor ID
- HBV / HBsAg 07-10 - Private Clinic
- Conditions
- CHRONIC HEPATITIS B
- Keywords
- HBsAg
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Nguyen Thi Trieu, MD
- First posted
- 10 Sep 2010 (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.
Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments.
Has stronger effect on immune system, effective good against HBV replication. This is a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.
Detailed description
Recent studies have proved Phyllanthus Urinaria - Adenosmatis Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. To made a clean jobs for HBV - DNA in the patient's body - hope this is a new step of medicine, will no longer exist phrase "chronic HBV infection " Methods of safety, therapeutic effect on expected cost savings should easily apply to everyone everywhere in the world. According to the investigation and must be called , Chronic HBV infection is an important worldwide cause of morbidity, mortality and source of potential new infections. There are an estimated 350 million carriers of HBV in the world. In China, Southeast Asia and sub-Saharan Africa, as many as 10-15% of the population are chronically infected. In North America and Northern Europe, infection and carrier rates are much lower, usually below 1%. Intermediate carrier rates of 1-5% are found in Southern Europe (e.g., Italy, Greece and Spain), parts of South and Central America, the Middle East and Japan. Persistent infection develops in over 90% of perinatally infected children and in 3-10% of people who become infected after the age of 6 years. Worldwide, it has been estimated that more than one million people die annually due to HBV-related end stage diseases such as cirrhosis and hepatocellular carcinoma.
The goal of antiviral therapy for hepatitis B is to reduce a patient's risks for progressive liver disease through prolonged suppression and eradication of HBV infection and to arrest or ameliorate HBV-related liver damage.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females ≥ 18 years of age with chronic and acute hepatitis B.
- Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months prior to entry.
- Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.
- Patients having treated or untreated
- Patients with compensated liver function (Child-Pugh score ≤ 6).
Key exclusion criteria (11 listed)
- Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months prior to study screening.
- Organ or bone marrow transplant recipients.
- Evidence of active liver disease to operate.
- Received immunoglobulins, interferon or other immune e to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
- Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
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 |
|---|---|---|
| CTH Chronic Hepatitis BAlso: - Ascorbic Acid, - Phyllanthus Urinaria, - Adenosma Glutinosum, - Eclipta ProstrataDrug: * Tenofovir * Phyllanthus Urinaria * Adenosma Glutinosum * Eclipta Prostrata * Ascorbic Acid | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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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.
Nguyễn Thị Triệu, Dr. study director
Tran Minh Duc, Dr.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTH Chronic Hepatitis B in people with CHRONIC HEPATITIS B, run by Nguyen Thi Trieu, MD at 2 sites in 2 countries.
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 6 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 15 Dec 2025.