Clinical Trials List
2017-11-01 - 2021-12-31
Others
Terminated9
ICD-10B18
Chronic viral hepatitis
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment(OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment
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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
- 盧勝男 無
- Jing-Houng Wang 無
- 郭垣宏 無
- 胡琮輝 無
- 紀廣明 無
- Wen-Chin Lee 無
- 張國欽 無
- 顏毅豪 無
- 洪肇宏 無
- 蔡明釗 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃惠君 無
- Chien-Wei Su 無
- 吳宏達 無
- Teh-Ia Huo 無
- 藍耿欣 無
- 黃以信 無
- 李癸汌 無
- 王苑貞 無
- Chi-Jen Chu 無
- Der-Cherng Tarng 無
The Actual Total Number of Participants Enrolled
4 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 葉宏仁 無
- CHUNG-HSIN CHANG 無
- TENG-YU LEE 無
- 陳家昌 無
- 呂宜達 無
- 黃儀倢 無
- 李少武 無
- 鄭友琦 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Taiwan National PI
Co-Principal Investigator
- Chien-Hao Huang 無
- Ya-Chung Tian 無
- I-Shyan Sheen 無
- Wen-Juei Jeng 無
- 鄭昌錡 無
- Yi-Cheng Chen 無
- Yi-Chung Hsieh 無
- 陳威廷 無
- 滕威 無
The Actual Total Number of Participants Enrolled
4 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Jia-Horng Kao Digestive System Department
- SHUEI-LIONG LIN Digestive System Department
- PEI-JER CHEN Digestive System Department
- 張允中 無
- Chen-Hua Liu Digestive System Department
- 楊宏志 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Jee-Fu Huang 無
- Chia-Yen Dai 無
- Ming-Lun Yeh 無
- Chung-Feng Huang 無
- Ming-Lung Yu 無
- 黃駿逸 無
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:
• Proportion of subjects achieving virologic response (plasma HBV DNA < 20 IU/mL ) at Week 24
The secondary efficacy endpoints are:
• Proportion of subjects achieving virologic response (plasma HBV DNA < 20 IU/mL ) at Weeks 48 and 96
• Proportion of subjects with plasma HBV DNA < 20 IU/mL and target detected/not detected (i.e.
< LLOD) at Weeks 24, 48, and 96
• Proportion of subjects with serological response (loss of HBsAg and seroconversion to anti-HBs, loss of HBeAg and seroconversion to anti-HBe in HBeAg-positive subjects) at Weeks 24, 48, and 96
• Proportion of subjects with biochemical response (normal ALT and normalized ALT) at Weeks 24, 48, and 96
• Change in fibrosis as assessed by FibroTest® at Weeks 24, 48, and 96
• Change from baseline in CPT score and MELD score at Weeks 24, 48, and 96 in hepatically impaired subjects
Other exploratory endpoints are:
• Effect of treatment on health related quality of life (via SF-36, CLDQ, WPAI, and EQ-5D-3L questionnaires) at Weeks 24, 48, and 96
2. Safety:
• Incidence of graded adverse events and graded laboratory abnormalities at Week 24
The secondary safety endpoints are:
• Incidence of graded adverse events and graded laboratory abnormalities at Week 48 and 96
• Change from baseline in eGFRCG at Weeks 24, 48, and 96 in subjects with moderate or severe
renal impairment and hepatically impaired subjects
• Percent change from baseline in hip and spine bone mineral density (BMD) at Weeks 24, 48, and 96
The exploratory safety endpoints are:
• Change from baseline in serum markers of bone turnover at Weeks 24, 48, and 96
• Change from baseline in urine markers of renal tubular dysfunction at Weeks 24, 48, and 96 in
subjects with moderate or severe renal impairment and hepatically impaired subjects
3. Pharmacokinetics:
Pharmacokinetic parameters will be listed and summarized for TAF and TFV using descriptive
statistics (e.g., sample size, arithmetic mean, geometric mean, % coefficient of variation, standard
deviation, median, minimum, and maximum) by study Part and cohort. Plasma concentrations
over time will be plotted in semi logarithmic and linear formats as mean ± standard deviation.
4. Quality of life:
• Health Related Quality of Life (HRQoL) Surveys (SF-36, CLDQ, WPAI, and EQ-5D-3L) at
Baseline, Weeks 24, 48, and 96/ED. The ED visit HRQoLs should be done if not done within
the last 24 weeks of this visit.
• Health Utilization Questionnaire will be administered by site staff at Baseline and at every
on-treatment visit thereafter
Inclution Criteria
All Subjects (Parts A and B):
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 or non-pregnant 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.
3) Documented evidence of chronic HBV infection (e.g. HBsAg positive for ≥ 6 months)
4) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
5) ALT ≤ 10 × upper limit of normal (ULN) at Screening by central laboratory
6) Must be willing and able to comply with all study requirements
Part A Only (renal impairment):
1) Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with
viral suppression (HBV DNA < LLOQ) for ≥ 6 months prior to Screening
• All subjects must have HBV DNA < 20 IU/mL at Screening by central laboratory
• Both HBeAg positive and negative subjects are eligible to participate
2) Moderate renal impairment (30 mL/min ≤ eGFRCG ≤ 59 mL/min), severe renal impairment (15
mL/min ≤ eGFRCG < 30 mL/min) using the Cockcroft-Gault equation, or ESRD (eGFR < 15
mL/min) maintained on HD
• eGFRCG is calculated by:
(140 – age in years) (actual body weight [kg])
(72) (serum creatinine [mg/dL])
(Note: multiply estimated rate by 0.85 for women)
• Stable renal function (for subjects with moderate or severe impairment): serum creatinine
measured at least once within three months prior to Screening. The measurement difference
between the value measured within three months prior to Screening versus the Screening value
must be ≤ 25% of the Screening value
Part B Only (hepatic impairment):
1) Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral
suppression (HBV DNA < LLOQ) for ≥ 6 months prior to Screening
• All subjects must have HBV DNA < 20 IU/mL at Screening by central laboratory
• Both HBeAg positive and negative subjects are eligible to participate
2) CPT score of 7-12 (inclusive) OR a past history of CPT score ≥ 7 and any CPT score ≤ 12 at
Screening
3) eGFRCG ≥ 30 mL/min using the Cockcroft-Gault equation:
• eGFRCG is calculated by:
(140 – age in years) (actual body weight [kg])
(72) (serum creatinine [mg/dL])
(Note: multiply estimated rate by 0.85 for women)
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not eligible to participate in the
study:
All Subjects (Parts A & B):
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.
3) Co-infection with HCV, HIV, or HDV
• Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
4) Prior Interferon (IFN) use within 6 months of Screening
5) Evidence of hepatocellular carcinoma (i.e. evidenced by imaging within 6 months of
Screening)
6) Received solid organ or bone marrow transplant
7) Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
8) 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
9) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents,
or agents capable of modifying renal excretion
10) Known hypersensitivity to study drugs, metabolites, or formulation excipients
11) Current alcohol or substance abuse judged by the investigator to potentially interfere with
subject compliance
12) 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.
13) Use of investigational agents within 3 months of Screening, unless allowed by the Sponsor
14) Use of any prohibited medication as described in Section.
Part A Only (renal impairment):
1) Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy
or variceal hemorrhage)
2) Abnormal hematological and biochemical parameters, including:
• Hemoglobin < 9 g/dL
• Absolute neutrophil count < 750/mm3
• Platelets ≤ 50,000/mm3
• AST > 10 × ULN
• Albumin < 3.0 g/dL
• Total bilirubin > 2.5 × ULN
• INR > 1.5 × ULN (unless stable on anticoagulant regimen)
3) Subjects with ESRD (i.e. eGFRCG < 15 mL/min) not on HD, or those on other forms of renal
replacement therapy (i.e. peritoneal dialysis)
Part B Only (hepatic impairment):
1) Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as
transjugular intrahepatic portosystemic shunt [TIPS])
2) History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic
encephalopathy, or spontaneous bacterial peritonitis within 6 months of Screening
3) Grade 2 hepatic encephalopathy at Screening
4) MELD score ≥ 30
5) Abnormal hematological and biochemical parameters, including
• Absolute neutrophil count < 750/mm3
• Platelets < 30,000/mm3
• Hemoglobin < 8.0 g/dL
The Estimated Number of Participants
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Taiwan
35 participants
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Global
156 participants
