Clinical trial NCT01198860: Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B
Official title: Tenofovir Disoproxil Fumarat 300 mg - Phyllanthus Urinaria 300mg - Adenosma Glutinosum 150mg - Eclipta Prostrata 150mg, Ascorbic Acid 500 mg Daily is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: CHRONIC HEPATITIS B
Keywords: HBsAg
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
First posted: 2010-09-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Saigon Biopharma LLC
state: Delaware
city: Hồ Chí Minh
country: Vietnam
facility: Saigon Biopharma Company Limited
state: Ho Chi Minh City
Study officials:
affiliation: Tran Minh Duc, Dr.
name: Nguyễn Thị Triệu, Dr.
role: STUDY_DIRECTOR
References: