Phase
Condition
Hepatitis B
Liver Disorders
Hepatitis
Treatment
TMF
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Must be able to understand and sign a written informed consent, which must be obtainedprior to screening.
- Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65years (based on the date of signed informed consent). Female subjects of childbearingage with a negative serum pregnancy test.
- Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6months.
- Subjects treated with ETV over 1 year will be able to be enrolled in the study.
- Subjects with 20 ≤ HBV-DNA < 2000 IU/mL at screening (including intermittent andcontinuous low-level viraeima).
- Must be willing and able to comply with all study requirements.
Exclusion
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding or who plan to become pregnantduring the study period.
- Men and women of childbearing potential who are unwilling to use an "effective" methodof contraception as defined in the protocol during the study period.
- Co-infection with HAV HCV, HIV, HDV or HEV; or co-infection with autologous liver,metabolism-related fatty liver, or drug-induced liver injury.
- Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellularcarcinoma)
- Patients who have received a solid organ or bone marrow transplant
- History of malignancy within 5 years prior to screening, except for specific tumorscured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluatedfor probable malignancy were ineligible.
- Currently receiving treatment with immunomodulators (e.g., corticosteroids),investigational drugs, nephrotoxic drugs, or drugs capable of regulating renalexcretion. Drugs that modulate renal excretion.
- Renal, cardiovascular, pulmonary, or neurological disease that is considered severe bythe investigator.
- Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesisimperfecta, chondromalacia) or multiple fractures.
- Subjects receiving a contraindicated combination drug (subjects receiving acontraindicated drug require a minimum 30-day washout period) and knownhypersensitivity reactions to study drugs, metabolites or formulation excipients.
- Current alcohol or drug abuse that, in the investigator's judgment, may interfere withthe subject's compliance with study requirements.
- Any other clinical condition that, in the opinion of the investigator, would renderthe subject unsuitable for the study or unable to comply with the dosing requirementsmedical condition or prior treatment.
- Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).
Study Design
Connect with a study center
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 400010
ChinaActive - Recruiting
Chongqing University Three Gorges Central Hospital
Chongqing, 400010
ChinaSite Not Available
Affiliated Hospital of Guangxi Medical University
Guangxi,
ChinaSite Not Available
Guizhou Provincial People's Hospital
Guiyang,
ChinaSite Not Available
Hepatobiliary disease of Jilin Province
Jilin,
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming,
ChinaSite Not Available
the Second People's Hospital of Yunnan Province
Kunming,
ChinaSite Not Available
Nanjing Second Hospital
Nanjing,
ChinaSite Not Available
The Second Hospital of Ningbo
Ningbo,
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai,
ChinaActive - Recruiting
Shuguang Hospital, Shanghai, China.
Shanghai,
ChinaSite Not Available
The Sixth People's Hospital of Shenyang
Shenyang,
ChinaSite Not Available
Shijiazhuang Fifth Hospital
Shijiazhuang,
ChinaSite Not Available
The First People's Hospital of Taicang
Taicang,
ChinaSite Not Available
The Fourth People's Hospital of Zibo
Zibo,
ChinaSite Not Available
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