Status:
UNKNOWN
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
HBV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investig...
Eligibility Criteria
Inclusion
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures;
- Male and female subjects,18 years of age and older, based on the date of the screening visit;
- Suboptimal Responders to Entecavir (defined as CHB patients treated with at least 12 months of ETV 0.5mg QD with prior suboptimal response viral load still detectable at week 48).
- ETV intolerance population (defined as unwilling or poor adherence to administer ETV in fasting food, renal impairment with ETV dosage adjustment required, pts with other unidentified reasons willing to switch, etc);
- Screening serum ALT level ≤ 10 × ULN;
- Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant);
- Must be willing and able to comply with all study requirements.
Exclusion
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study;
- Co-infection with HCV, HIV, or HDV;
- Any history of, or current evidence of, clinical hepatic decompensation (i.e., moderate-severe ascites, encephalopathy or variceal hemorrhage);
- Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging);
- Abnormal hematological and biochemical parameters, including: Hemoglobin \< 10 g/dl, Absolute neutrophil count \< 0.75×109/L, Platelets ≤ 50×109/L, AST or ALT \> 10 × ULN, Total bilirubin \> 2.5 × ULN, Albumin \< 3.0 g/dl, INR \> 1.5 × ULN;
- Received solid organ or bone marrow transplant;
- Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication);
- Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease);
- Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator;
- Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection(basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible;
- Known hypersensitivity to study drugs, metabolites, or formulation excipients;
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance;
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04034368
Start Date
August 1 2019
End Date
June 1 2021
Last Update
July 26 2019
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