Clinical Trials List
2013-12-01 - 2022-12-31
Phase III
Terminated8
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
Gilead Sciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 邱彥程 Digestive System Department
- Pin-Nan Cheng Digestive System Department
- 吳毅晉 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 葉宏仁 Digestive System Department
- TENG-YU LEE Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
- 童春芳 Digestive System Department
- 呂宜達 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 盧勝男 Digestive System Department
- 陳建宏 Digestive System Department
- 張國欽 Digestive System Department
- 洪肇宏 Digestive System Department
- 曾柏霖 Digestive System Department
- Jing-Houng Wang Digestive System Department
- 紀廣明 Digestive System Department
- 胡琮輝 Digestive System Department
- 顏毅豪 Digestive System Department
- 郭垣宏 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi-Cheng Chen Digestive System Department
- Chau-Ting Yeh Digestive System Department
- Chen-Chun Lin Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳立偉 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Lun Yeh Digestive System Department
- Jee-Fu Huang Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊宏志 Digestive System Department
- Chun-Jen Liu Digestive System Department
- Chien-Hung Chen Digestive System Department
- Chen-Hua Liu Digestive System Department
- 蘇東弘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
2.Tenofovir Disoproxil Fumarate (TDF, Viread®)
Active Ingredient
Tenofovir Disoproxil Fumarate
Dosage Form
Dosage
300 mg
Endpoints
the treatment of HBeAg-negative, chronic hepatitis B at Week 48 in treatment-naïve and treatment-experienced subjects.
The primary efficacy parameter is the proportion of subjects with plasma HBV DNA levels below 29 IU/mL.
• To compare the safety and tolerability of TAF 25 mg QD versus TDF 300 mg QD for the treatment of HBeAg-negative, chronic
hepatitis B at Week 48 in treatment-naïve and treatmentexperienced subjects
Inclution Criteria
study procedures.
2. Male and non-pregnant, non-lactating female subjects, 18 years of age and older, 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 6).
3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
4. HBeAg-negative, chronic hepatitis B with all of the following:
• HBeAg-negative and HBeAb positive at Screening (if the subject is deemed ineligible for this study by HBV serology
[i.e. HBeAg positive CHB], this information may be used to determine eligibility for GS-US-320-0110 [another Gilead
Sciences Phase 3 study in HBeAg-positive, CHB subjects; this study must also be IRB/EC approved at the
participating center])
• Screening HBV DNA ≥ 2 x 104 IU/mL
• Screening serum ALT level > 60 U/L (males) or > 38 U/L
(females) and ≤ 10 × ULN (by central laboratory range)
5. Treatment-naïve subjects (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue),
OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serum ALT criteria]
and with ≥12 weeks of previous treatment with any nucleoside or nucleotide analogue) will be eligible for enrollment.
Treatment-experienced subjects receiving oral antiviral treatment at Screening must continue their treatment regimen
until the time of randomization, when it will be discontinued.
6. Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the
baseline visit.
7. Estimated creatinine clearance (CLCr) ≥ 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]
8. Normal ECG (or if abnormal, determined by the investigator not to be clinically significant)
9. Must be willing and able to comply with all study requirements.
Exclusion Criteria
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 6.
3. Co-infection with HCV, HIV, or HDV
4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging)
5. Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal
hemorrhage)
6. Abnormal hematological and biochemical parameters, including:
— Hemoglobin < 10 g/dL
— Absolute neutrophil count < 750/mm3
— Platelets ≤ 50,000/mm3
— AST or ALT > 10 x ULN
— Total bilirubin > 2.5 x ULN
— Albumin < 3.0 g/dL
— INR > 1.5 x ULN (unless stable on anticoagulant regimen)
7. Received solid organ or bone marrow transplant
8. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
9. Significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or
multiple bone fractures
10. Malignancy within 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
11. Currently receiving therapy with immunomodulators (e.g., corticosteroids), investigational agents, nephrotoxic
agents, or agents capable of modifying renal excretion
12. Known hypersensitivity to study drugs, metabolites, or formulation excipients
13. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
14. 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.
15. Subjects on prohibited concomitant medications (See Table 5.1). Subjects on prohibited medications, otherwise eligible,
will need a wash out period of at least 30 days.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
390 participants
