– Helping the poor who do not have money to attend treatment. Need community support to develop preparations for the global market of pharmaceutical products used to treat chronic viral hepatitis B, liver cell regeneration in cirrhosis at an early stage, prevent epithelial cancer Liver cells, and prevent relapse of liver cancer. Support treatment for chronic hepatitis C and cirrhosis due to Hepatitis C The drug has been tracking stability and safety in humans> 10 years; 100% on cases virus-cleans.

-Helping the poor who do not have money to attend treatment.

- The goal is to reduce the incidence of chronic hepatitis B; reduced rates of cirrhosis and hepatocellular carcinoma due to hepatitis B; hepatitis C worldwide.

Reduce the burden of health costs for society.

Commitment to drugs available on the market with the lowest cost.

- ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt

Release Date: April 24, 2020

ClinicalTrials.gov ID: NCT01198860

Study Identification

Unique Protocol ID: HBsAg 07-10 - SAIGON BIOPHARMA COMPANY LIMITID

Brief Title: Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B ( HBV )

Official Title: Tenofovir Disoproxil Fumarate - Phyllanthus Urinaria - Adenosmatis

Glutinosum - Eclipta Prostrata, Ascorbic Acid daily is

Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.

Secondary IDs:

Study Status

Record Verification: April 2020

Expanded Access Status: Approved for marketing

Sponsor/Collaborators

Sponsor: Triệu, Nguyễn Thị, M.D.

Responsible Party: Sponsor-Investigator

Investigator: Triệu, Nguyễn Thị, M.D. [trieut]

Official Title: Trần Minh Đức

Affiliation: Triệu, Nguyễn Thị, M.D.

Collaborators:

Oversight.

Compare.

U.S. FDA IND/IDE: No

Study Description

Brief Summary: Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic

Acid combination plus Tenofovir in the treatment of acute and chronic hepatitis

B. Method the combination of drugs derived from natural and artificial medicaments.

It has a stronger effect on the immune system, effective good against HBV replication.

This is a substantial new insight into the pathogenesis of the 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 the treatment of acute and chronic hepatitis B. Method the combination of drugs derived from

natural and artificial medicaments. To make 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 the 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 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

Conditions: CHRONIC HEPATITIS B

Keywords: HBsAg

Study Design

Study Type: Expanded Access

Interventions

Interventions Drug: CTH Chronic Hepatitis B

Other Names:

- Ascorbic Acid

- Phyllanthus

- Adenosmatis Glutinosum

- Eclipta Prostrata

- Tenofovir

Eligibility

Minimum Age: 18 Years

Maximum Age: 60 Years

Sex: All

Gender-Based:

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 before entry.

• Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.

• Patients having treated or untreated

• Patients with compensated liver function (Child-Pugh score ≤ 6).

• Informed written 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 before 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 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 is other than hepatitis B.

• History of hypersensitivity to nucleoside analogs.

• Women of childbearing potential not practicing adequate contraception.

• Pregnancy or lactation.

Contacts/Locations

Central Contact Person: Nguyễn Thị Triệu, Dr.

Telephone: (84)903640722

Email: [email protected]

Central Contact Backup: Trần Minh Đức, Dr.

Telephone: (84)906640722

Email: [email protected]

Study Officials: Nguyễn Thị Triệu, Dr.

Study Director

Tran Minh Duc, Dr.

Locations: Vietnam

SAIGON BIOPHARMA COMPANY LIMITED

Hồ Chí Minh, Ho Chi Minh City, Vietnam, 700000

Contact: Nguyễn Thị Triệu, Dr. ( 84 ) 903640722

[email protected]

Contact: Trần Minh Đức, Dr. ( 84 )906640722

[email protected]

Principal Investigator: Nguyễn Thị Triệu, Dr.

References

Citations:

Links:

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services