Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01475851
Eligibility Criteria:
Inclusion Criteria:
* The ability to understand and sign a written informed consent form
* 16 to 69 years of age at the time of informed consent
* Females of childbearing potential must have a negative pregnancy test and agree to avoidance of pregnancy
* Subject must show QTc \<450 millisecond (msec) or \<480msec with Bundle Branch Block
* Chronic HBV infection, defined as positive serum HBsAg for at least 6 month
* Subjects currently treated with LAM/ADV, ETV or ETV/ADV for greater than 24 weeks
* Chronic hepatitis B ; HBV NDA \>= 4 log10 copies/mL, Chronic hepatitis B with cirrhosis ; HBV NDA \>= 3 log10 copies/mL
* Serum ALT \<= 10 × ULN
* Creatinine clearance \>= 70 mL/min
* Haemoglobin \>= 8 g/dL
* WBC \>= 1,000 /mm3
Exclusion Criteria:
* Decompensated liver disease
* Co-infection with HIV or HCV
* Autoimmune hepatitis rather than chronic hepatitis B
* Subject with serious complication
* Received or have a plan for solid organ or bone marrow transplantation
* Has proximal tubulopathy
* History of hypersensitivity to nucleoside and/or nucleotide analogues
* Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum α-fetoprotein \> 50 ng/mL at screening
* History of HCC
* Received any interferon or HB vaccine therapy within 24 weeks prior to initiation
* Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to initiation
* Received drugs for injection containing glycyrrhizin as the main component within 4 weeks prior to initiation
* Received drugs causing renal impairment, competitors of renal excretion, immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to initiation
* Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study
* Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the study period
* Psychiatry disorder or cognitive disorder that may affect the subject ability to give informed consent or to follow specified study procedures
* History of alcohol or drug abuse
* Any condition or situation that may interfere with the subject's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
69 Years
Study:
NCT01475851
Study Brief:
Protocol Section:
NCT01475851