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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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The goal of this a clinical trial is to learn about the efficacy,safety and Pharmacokinetics of Hepenofovir Fumarate Tablets(HTS) in patients with CHB. The main questions it aims to answer are:
Positive control drug:Tenofovir alafenamide Fumarate tablets(25mg/d) Test drug:Hepenofovir Fumarate Tablets(10mg/d、20mg/d、40mg/qod) Test process:This study was divided into 4 groups, with the specific list shown below. The initial plan was to include 12 subjects in each group, stratified by HBeAg status, with 4 subjects negative for HBeAg and 8 subjects positive for HBeAg. A total of 48 subjects were included in this trial, and they were randomly assigned to multiple doses at a ratio of 1:1:1:1. The dosing period was 24 weeks. However, after enrolling 37 subjects (29 positive for HBeAg and 8 negative for HBeAg), the protocol was adjusted (V4.0): the remaining 11 subjects would be included, all of whom were over 30 years old with ALT < ULN and met all the inclusion criteria but none of the exclusion criteria. The random assignment was: 7 subjects positive for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 2:2:2:1; and 4 subjects negative for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 1:1:1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir alafenamide Fumarate tablets | Active Comparator | TAF is taken orally under postprandial conditions, and subjects begin eating breakfast within 30 minutes of taking the drug. The 25mgQD group is given a single daily dose for 24 consecutive weeks, and continues to take the drug for 48 weeks after completing the 24-week treatment. |
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| Hepenofovir Fumarate Tablets | Experimental | After taking HTS tablets orally under postprandial conditions, subjects began to eat breakfast within 30 minutes before taking the drug. The 10mgQD and 20mgQD dose groups were administered once daily for 24 consecutive weeks, and continued to be administered for 48 weeks after completing the 24-week treatment. The 40mgQOD group was administered once every other day for 24 weeks, and continued to be administered for 48 weeks after completing the 24-week treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepenofovir Fumarate Tablets | Drug | Each subject received multiple doses of the test drug/control drug and completed safety, efficacy, and PK evaluations |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantification of HBV DNA | HBV DNA | Screening period,week2(Day15±3),week4(Day29±3),week8(Day57±3),week12 (Day85±5),week16(Day113±5),week20(Day141±5),week24(Day169±5),week28(Day197±5), week32(Day225±5),week36(Day253±5),week40(Day281±5),week44(Day309±5),week48(Day335 QOD or Day336QD ±5) |
| Quantification of HBV markers | HBsAg ,HBeAg | Day1 before administration,week12(Day85±5),week24(Day169±5), week36(Day253±5),week48(Day335 QOD or Day336QD ±5) |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Symptoms and physical examination, clinical laboratory tests (blood routine, blood biochemistry, coagulation profile, urine routine, thyroid function test), thyroid ultrasound, abdominal ultrasound, vital signs (blood pressure, pulse, respiration and body temperature), 12-lead electrocardiogram, bone density, monitoring and recording of adverse events and concomitant medication. | during the intervention、within 4 weeks of completion of treatment |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of HTS and TFV | The experimental group measured the concentrations of hepranofovir and tenofovir (TFV), while the control group measured the concentrations of tenofovir (TFV) | 0min,15min,30min,1hour,1.25hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour,24hour,48hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ding Yanhua, Master | Contact | 18743062721 | 1023307193@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Jilin City | Changchun | China |
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