NCT02792088已完成3 期
A Phase III, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week
研究概览
简要总结
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients
详细描述
- Screening Period Subject registration is conducted with confirming selection and exclusion criteria after a written consent form is obtained within 42 days before clinical trial drug administration.
- Baseline Subjects who visit on the date of starting clinical trial drug administration are randomized to a test group or a control group at a ratio of 1:1. Double blindness is applied for both groups.
- Treatment period Subjects are orally administered with a clinical trial drug q.ds.i.d. for 48 weeks and visit at the 0, 4th, 12th, 24th, 36th, and 48th week for an HBV DNA test, laboratory tests, a physical test, vital signs, and adverse events.
- Follow-up period Subjects are provided with appropriate treatment after completing the 48-week trial or dropping out. Subjects visit once at the 60th week for follow-up of adverse events, such as acute deterioration of hepatitis B, and HBV DNA test results. If any treatment is not conducted after 48-week administration, subjects visit at intervals of four weeks until a follow-up visit (60th week) and the same tests with the 24th week visit (Visit 5) are conducted. However, subjects who participate in a 48-week separate extended trial conducted after 48-week administration in this clinical trial do not have a follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
- •Patients who showed positive HBsAg during screening
- •Have developed nucleoside analogue resistant HB
- •Had no received nucleotide analogue
排除标准
- •Treatment with pegylated interferons within 6 months
- •Prior exposure to BSV
- •Mutations conferring resistance to ADV
- •Serum HBV DNA levels < 69 IU/mL
- •Coinfection with hepatitis C, hepatitis D or human immunodeficiency viruses
- •ALT levels ≥ 10 x ULN
- •Evidence of decompensated liver disease (Total bilirubin > 2 x ULN, prothrombin time > 6 sec prolonged or INR >1.5, serum albumin <2.8 g/dL, uncontrolled ascites, overt hepatic encephalopathy, or Child-Pugh score ≥8)
- •Certain laboratory abnormalities (Hemoglobin < 9.0 g/dL, absolute neutrophil count (ANC) < 1 x 109/L (1000/mm3), platelet count < 75 x 109/L (75 x 103/mm3), serum Creatinine > 1.5 mg/dL, or serum amylase > 2 x ULN and Lipase > 2 x ULN)
- •Decreased estimated glomerular filtration rates < 50 mL/min
- •Presence of hepatocellular carcinoma or elevated alpha feto-protein > 50 ng/mL
- •Current use of aspirin or nonsteroidal anti-inflammatory drugs within 2 month
- •Current use of immunosuppressive agents within 6 months
- •Current use of high dose corticosteroids (prednisolone > 20 mg/day or equivalent dose over 14 days) with 3 months
- •History of malignancy within 5 years
- •Subjects who are participating in other clinical trials
- •Pregnant or lactating women
- •Hypersensitivity to the study drugs
研究组 & 干预措施
Besifovir
Experimental
Besifovir 150 mg q.d.
干预措施: Besifovir 150mg (Drug)
Tenofovir
Active Comparator
Tenofovir 300 mg q.d.
干预措施: Tenofovir 300mg (Drug)
结局指标
主要结局
The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week
时间窗: at the 48th week
次要结局
- The rate of subjects who showed ALT normalized at the 48th week(at the 48th week)
研究者
研究点 (1)
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