Tenofovir Disoproxil Fumarat , Herbal Medicaments, Vitamin C Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B (HBV)

Expanded access is currently available for this treatment.
Verified May 2015 by Triệu, Nguyễn Thị, M.D.
Sponsor:
Information provided by (Responsible Party):
Triệu, Nguyễn Thị, M.D.
ClinicalTrials.gov Identifier:
NCT01198860
First received: September 4, 2010
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

Phyllanthus Cantoniensis Hornem - Herba Adenosmatis Caerulei - Herba Eclipta - Vitamin C 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.


Condition Intervention Phase
CHRONIC HEPATITIS B
Drug: CTH Chronic Hepatitis B
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: Tenofovir Disoproxil Fumarat 300 mg - Phyllanthus Cantoniensis Hornem 300mg - Herba Adenosmatis Caerulei 150mg - Herba Eclipta 150mg, Vitamin C 500 mg Daily is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.

Resource links provided by NLM:


Further study details as provided by Triệu, Nguyễn Thị, M.D.:

Study Start Date: September 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CTH Chronic Hepatitis B

    Drug:

    Tenofovir/ 300mg daily Phyllanthus Cantoniensis Hornem/300mg daily Herba adenosmatis caerulei/150mg daily Herba Eclipta /150mg daily Vitamin C / 500mg daily

    Other Names:
    • Vitamine C
    • Phyllanthus cantoniensis Hornem
    • Herba adenosmatis caerulei
    • Herba Eclipta
    • Tenofovir 300 mg
Detailed Description:

Recent studies have proved Phyllanthus Cantoniensis Hornem - Herba Adenosmatis Caerulei - Herba Eclipta - Vitamin C 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198860

Contacts
Contact: Nguyễn Thị Triệu, Bachelor (84)0903640722 trieunguyenthi@ymail.com
Contact: Trần Minh Đức, Master (84)0937244572 trieu.nguyenthi@yahoo.com.vn

Locations
Vietnam
Private Clinic
Hồ Chí Minh, Ho Chi Minh City, Vietnam, 70000
Contact: Nguyễn Thị Triệu, Bachelor    ( 84 ) 0903640722    trieunguyenthi@ymail.com   
Contact: Trần Minh Đức, Master    ( 84 )0937244572    trieu.nguyenthi@yahoo.com.vn   
Principal Investigator: Nguyễn Thị Triệu, Bachelor         
Sponsors and Collaborators
Triệu, Nguyễn Thị, M.D.
Investigators
Study Director: Nguyễn Thị Triệu, Bachelor Private Clinic
  More Information

No publications provided

Responsible Party: Triệu, Nguyễn Thị, M.D., Trần Minh Đức
ClinicalTrials.gov Identifier: NCT01198860     History of Changes
Other Study ID Numbers: HBsAg 07-10 - Private Clinic
Study First Received: September 4, 2010
Last Updated: May 26, 2015
Health Authority: Vietnam: Ho Chi Minh City Health Service

Keywords provided by Triệu, Nguyễn Thị, M.D.:
HBsAg

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ascorbic Acid
Tenofovir
Tenofovir disoproxil
Vitamins
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antioxidants
Antiviral Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 30, 2015