Status:
UNKNOWN
A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
Lead Sponsor:
Cheng-Chung Wei
Collaborating Sponsors:
Golden Biotechnology Corporation
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
Primary Objective: To evaluate the activity of Antroquinonol in patients with chronic hepatitis B Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with...
Detailed Description
This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with chronic hepatitis B. The study is conducted in complian...
Eligibility Criteria
Inclusion
- Inclusion criteria -
- Chronic HBV infection patients between the ages of 20 and 75 years with serum hepatitis B surface antigen(HBsAg) positivity for more than 6 months
- BMI≦35
- HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.
- GOT or GPT ≧ 25 IU
- Female subject must use effective methods of contraception
- No abnormal finding of clinical relevance
- Written informed consent
- Exclusion criteria -
- Evidence of hepatic decompensation such as:
- Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds
- Total bilirubin of 2 times the upper limit of normal
- FIB-4 of 3.25 or greater
- Abnormal hematological and biochemical parameters at screening
- White blood cell count less than 2500 cells/uL
- Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects)
- Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females
- Estimated GFR less than 50 mL/min
- Suspected or confirmed liver diseases from etiologies other than HBV (such as alcohol, toxin, drug, shock, acute viral hepatitis A or E), co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis delta virus, prior antiviral treatment with NUCs or interferon, and recent immunosuppressive therapy (including chemotherapy and systemic corticosteroid).
- Immunodeficiency disorders or severe autoimmune disease
- Severe pulmonary disorders or significant cardiac diseases
- Gastrointestinal disorder with post-operative condition that could interfere with drug absorption
- Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein \> 50ng/mL or radiologic evidence)
- Solid organ transplantation
- Current drug or alcohol abuse
- Pregnancy or lactation
- Under hepatitis B antiviral or interferon treatment within 3 months
Exclusion
Key Trial Info
Start Date :
August 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04112147
Start Date
August 10 2018
End Date
June 30 2020
Last Update
October 2 2019
Active Locations (1)
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1
Chung Shan Medical University hospital
Taichung, Taiwan, 402