Clinical Trials List
2017-03-21 - 2020-07-21
Phase III
Terminated5
ICD-10B18.9
Chronic viral hepatitis, unspecified
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Cheng-Yuan Peng 未分科
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 楊宏志 Digestive System Department
- Chen-Hua Liu Digestive System Department
- PEI-JER CHEN Digestive System Department
- Chien-Hung Chen Digestive System Department
- Chun-Jen Liu Digestive System Department
- 張允中 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint is the proportion of subjects with HBV DNA ≥ 20 IU/mL
(as determined by the modified US FDA-defined snapshot algorithm) at Week 48.
Inclution Criteria
Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
1) Must have the ability to understand and sign a written informed consent form; consent must
be obtained prior to initiation of study procedures
2) Adult male and non-pregnant, non-lactating female subjects, ≥18 years of age based on the
date of the screening visit. A negative serum pregnancy test at Screening is required for
female subjects of childbearing potential (as defined in Appendix 5).
3) Documented evidence of chronic HBV infection previously (e.g., documented HBsAg
positive for more than 6 months)
4) Maintained on TDF 300 mg QD for at least 48 weeks, and as monotherapy for CHB for at
least 24 weeks prior to screening and with viral suppression (HBV DNA < LLOQ by local
laboratory assessment) for a minimum of 12 weeks prior to Screening, and including a
Screening HBV DNA value of < 20 IU/mL (by central laboratory)
5) Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on
serum creatinine and actual body weight as measured at the Screening evaluation, as follows:
(140 – age in years) (body weight [kg])/(72) (serum creatinine [mg/dL])
(Note: multiply estimated rate by 0.85 for women)
6) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
7) Must be willing and able to comply with all study requirements
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
1) Pregnant women, women who are breastfeeding or who believe they may wish to become
pregnant during the course of the study
2) Males and females of reproductive potential who are unwilling to use an “effective”,
protocol-specified method(s) of contraception during the study. For a list of
protocol-specified Contraceptive methods, refer to Appendix 5.
3) Co-infection with HCV, HIV, or HDV
Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
4) Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging)
5) Current evidence of, or recent (≤ 5 years) history of clinical hepatic decompensation
(e.g., ascites, encephalopathy or variceal hemorrhage)
6) Abnormal hematological and biochemical parameters, including:
a) Hemoglobin < 10 g/dL
b) Absolute neutrophil count < 750/mm3
c) Platelets ≤ 50,000/mm3
d) AST or ALT > 5 × ULN
e) Albumin < 3.0 mg/dL
f) INR > 1.5 × ULN (unless stable on anticoagulant regimen)
g) Total bilirubin > 2.5 × ULN
7) Received solid organ or bone marrow transplant
8) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
9) Malignancy within 5 years prior to Screening, with the exception of specific cancers that are
cured by surgical resection (e.g. basal cell skin cancer, etc.). Subjects under evaluation for
possible malignancy are not eligible.
10) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic
agents, or agents capable of modifying renal excretion
11) Known hypersensitivity to study drugs, metabolites, or formulation excipients
12) Current alcohol or substance abuse judged by the investigator to potentially interfere with
subject compliance
13) 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.
14) Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
15) Use of any prohibited medications as described in Section 5.4. Subjects on prohibited
medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Baseline visit.
The Estimated Number of Participants
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Taiwan
70 participants
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Global
460 participants
