Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B

Status:

APPROVED_FOR_MARKETING

Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B

Lead Sponsor:

Nguyen Thi Trieu, MD

Conditions:

CHRONIC HEPATITIS B

Eligibility:

All Genders

18-60 years

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 na...

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 combin...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01198860

Last Update

December 15 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

Saigon Biopharma LLC

Wilmington, Delaware, United States, 19801-6601