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

Primary Purpose

CHRONIC HEPATITIS B

Status

Approved for marketing

Phase

Locations

Vietnam

Study Type

Expanded Access

Intervention

CTH Chronic Hepatitis B

About this trial

This is an expanded access trial for CHRONIC HEPATITIS B focused on measuring HBsAg

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Saigon Biopharma Company Limited

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01198860

First Posted

September 4, 2010

Last Updated

October 6, 2021

Sponsor

Nguyen Thi Trieu, MD

1. Study Identification

Unique Protocol Identification Number

NCT01198860

Brief Title

Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B

Acronym

HBV

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Approved for marketing

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nguyen Thi Trieu, MD

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CHRONIC HEPATITIS B

Keywords

HBsAg

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CTH Chronic Hepatitis B

Other Intervention Name(s)

- Ascorbic Acid, - Phyllanthus Urinaria, - Adenosma Glutinosum, - Eclipta Prostrata, - Tenofovir

Intervention Description

Drug: Tenofovir/ 300mg daily Phyllanthus Urinaria/300mg daily Adenosma Glutinosum/150mg daily Eclipta Prostrata/150mg daily Ascorbic Acid / 500mg daily

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nguyễn Thị Triệu, Dr.

Organizational Affiliation

Tran Minh Duc, Dr.

Official's Role

Study Director

Facility Information:

Facility Name

Saigon Biopharma Company Limited

City

Hồ Chí Minh

State/Province

Ho Chi Minh City

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

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Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B

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