Clinical Trials List
2013-12-01 - 2022-12-31
Phase III
Terminated11
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-Positive, Chronic Hepatitis B
-
Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
-
Sponsor
Gilead Sciences, Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 吳毅晉 Digestive System Department
- Pin-Nan Cheng Digestive System Department
- 邱彥程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳昇弘 Digestive System Department
- Hung-Yao Chen Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 蘇文邦 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 梁程超 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 洪肇宏 Digestive System Department
- 曾柏霖 Digestive System Department
- 盧勝男 Digestive System Department
- 陳建宏 Digestive System Department
- 張國欽 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
- Jee-Fu Huang Digestive System Department
- Ming-Lun Yeh 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
- Chun-Jen Liu Digestive System Department
- Chien-Hung Chen Digestive System Department
- 楊宏志 Digestive System Department
- Chen-Hua Liu Digestive System Department
- 蘇東弘 Digestive System Department
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
• To compare the efficacy of tenofovir alafenamide (TAF) 25 mg QD versus tenofovir disoproxil fumarate (TDF) 300 mg QD for
the treatment of HBeAg-positive, 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-positive, chronic
hepatitis B at Week 48 in treatment naïve and treatmentexperienced subjects The key secondary safety objectives of this study are as follows:
• To compare the safety of TAF 25 mg QD versus TDF 300 mg QD as determined by the percent change from baseline in hip and
spine bone mineral density (BMD) at Week 48
• To compare the safety of TAF 25 mg QD versus TDF 300 mg QD as determined by the change from baseline in serum creatinine 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, which must be obtained prior to initiation of 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.
3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
4. HBeAg-positive, chronic hepatitis B with all of the following:
⎯ HBeAg-positive at Screening (if the subject is deemed ineligible for this study by HBV serology
[i.e. HBeAg-negative CHB], this information may be used to determine eligibility for GS-US-320-0108 [another Gilead
Sciences Phase 3 study in HBeAg-negative, 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 x 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 Error! Reference source not found..
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 (i.e., 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 (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or
multiple bone fractures.
10. 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.
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. Subjects on prohibited medications, otherwise eligible, will need a
wash out period of at least 30 days.
The Estimated Number of Participants
-
Taiwan
110 participants
-
Global
864 participants
