A Single-Arm Study Evaluating the Efficacy of Liquid Acupuncture Therapeutics in Chronic Hepatitis B

NCT00815464 | Unknown DMC

• 1 other identifier: YMG-PR-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Purpose: The purpose of this study is to assess that Liquid Acupuncture(Herb Acupoints Injection) Therapeutics could achieve permanent efficacy response in Chronic Hepatitis B. Efficacy Assessment: At cessation of the Treatment(about at 24 weeks)comparing Testing Data with the Normal Criteria and their individual baseline.Continue for monitoring the Status 1-5 years. Data Analysis: Each 4 weeks collecting Patients' testing data and fill a table.A summary table will be presented as frequency tables for categorical variables as number or percentage.

Conditions

Hepatitis B, Chronic; Liver Diseases; Virus Diseases; Hepatitis; Diffuse Hepatic Disease

Keywords

Chronic Hepatitis B; Liquid Acupuncture(Herb Acupoint Injection); Therapeutics; Herbalist; Acupoint

Outcome Measures

Primary Outcomes (1)

• Permanent Efficacy response after whole treatment circle close(about 24-48 weeks): 1、HBeAg loss(if HBeAg positive) 2、HBV DNA non-detectability (PCR <500 copies/ml) 3、Liver function normal(If Liver function off normal)

  1-2 years

Secondary Outcomes (1)

• HBsAg titer will decrease continually up to loss after cessation of the treatment.

  one year later

Study Arms (1)

Antiviral Therapy

EXPERIMENTAL

Liquid Acupuncture(Herb Acupoints Injection) Therapeutics was researched and developed by Herbalist Yu Ru Lin in early of 1950s and used by Yu Medical Garden till now. It is an integrated therapeutics,according to individual condition, select the Acupoints(not limit to current used common acupoints) and proper herbs made individually.It is a special medical treatment conception, which theory is utilizing patients' condition, mobilizing their individual internal curability,therefore the final efficacy can be retrieved.

Device: Liquid Acupuncture (Herb Acupoint Injection)

Interventions

Liquid Acupuncture (Herb Acupoint Injection) DEVICE

Each 4 weeks per one circle.The first 3 weeks for treatment practice(one per week)and the last week for test collection.

Also known as: Antiviral Agents

Antiviral Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects aged 18-55 years inclusive.
• Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months.
• Serum HBV DNA ≥ 10\^4 copies/mL(PRC).
• Use of interferon alfa, thymosin, or antiviral agents less than 1 year and not receive them more than 2 months. (If you expect to stop these agents but worry about the risk, you may ask us to help.)
• Agree not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study.
• Able to give written informed consent and comply with the requirements of the study.

You may not qualify if:

• Superinfection/Coinfection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
• Autoimmune hepatitis (antinuclear antibody titre \> 1:160).
• Use of interferon alfa, thymosin, or antiviral agents more than 1 year.
• Pregnant or nursing.
• Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
• Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:serum bilirubin \> 2.5 mg/dL (≤ 43 µmol/L), prothrombin time \> 2 second prolonged above ULN,serum albumin \< 35g/L,history of ascites, variceal bleeding, or encephalopathy,Alanine aminotransferase (ALT) \>10 times ULN at screening or history of acute exacerbation leading to transient decompensation.
• Hepatocellular carcinoma as evidenced by one of the following:
• suspicious foci on ultrasound or radiological examination.
• where no positive ultrasound finding, but serum alpha-fetoprotein \> 100ng/mL
• Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
• Received hepatotoxic drugs (e.g., anabolic steroids, ketaconazole, itraconazole, isoniazid, rifampin, rifabutin) within 2 months prior to study screening or expected to receive these during the course of the study.
• Received nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that patient will receive any of these during the course of the study.
• Receiving systemic (intravenous 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.
• Neutrophile granulocyte count \<1.0\*10e9/L and Platelet count \< 30\*10e9/L.
• Inability to comply with study requirements.

Sponsors & Collaborators

• Yu Medical Garden: lead

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Diseases; Virus Diseases; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke Heng Yu

  Yu Medical Garden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Heng Yu

CONTACT

+86 13752305455; hailinhospital@yahoo.com.cn

Ya Hua Yu

CONTACT

+86 13920733517; zhguantian@tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: December 30, 2008

Record last verified: 2008-12