NCT02966964Unknown2 期
An Exploratory, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With Hepatitis B Virus(HBV)
Uijeongbu St. Mary Hospital6 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- The proportion of normalization of ALT level (≤1× ULN)(%)
研究概览
简要总结
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly.
All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at the age in between 19 and 69 years at the time of agreement
- •Patients who had HBsAg-positive at least within 24 weeks or had a diagnosis with chronic hepatic disease by image test within 24 weeks from the time of screening.
- •Patients who had HBeAg-positive and HBV DNA level≥20,000 IU/mL, or HBeAg-negative and HBV DNA level≥2,000 IU/mL
- •Patients never treated with Tenofovir
- •Patients whose ALT level is more than 2 times of UNL at the time of screening
- •Patients prothrombin time prolonged≤4sec at the time of screening
- •Patients Total bilirubin level≤3.0mg/dL at the time of screening
- •Patients albumin level≥3.0g/dL at the time of screening
- •Patients ELF score≥8.5 at the time of screening
- •Patients who agree with the clinical trial voluntarily and sign on the agreement
排除标准
- •HIV, HCV or HDV infedted patients
- •Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)
- •Patients who had suffered from variceal haemorrhage or hepatic encephalopathy
- •Patients who need/had liver transplant
- •Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis
- •Patients who have enteritis and colitis like peptic ulcer or Crohn's disease
- •Patients who have significant kidney disease, cardiovascular disease, lung disease, nervous disease, self-immune disease, bone disease (ex: osteomalacia, osteopenia, chronic osteomyelitis, osteopsathyrosis, osteochondrosis, multiple fracture) or malignant tumor.
- •Patients who have systemic infection
- •Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir
- •Patients who have the generic problem as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients described as below at the time of screening
- •Hb<8g/dL
- •eGFR<60mL/min/1.73m2
- •AFP level>200ng/mL or had a diagnosis with hepatocellular carcinoma based on the radiology result within 24 weeks
- •Patients who had immune- or cytokine-based antiviral agents treatment (ex. Interferon α, Peginterferon α), or immunosuppression therapy (ex. Cyclosporine, Tacrolimus) in 24 weeks at the time of screening
- •Patients who have to use the contraindication of comedication drugs during clinical trial or can't get the wash-out period
- •Women of child-bearing potential not using an effective birth control method
- •Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand the purpose and process of this clinical trial
- •Patients who participated in other clinical trial in 30 days prior to the enrollment in this study
- •Patients who were determined inappropriate by the investigator to participate in this study
研究组 & 干预措施
Tenofovir 300mg qd + DWPUR001 300mg bid
Experimental
Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months
干预措施: DWPUR001 (Drug)
Tenofovir 300mg qd + DWPUR001 500mg bid
Experimental
Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months
干预措施: DWPUR001 (Drug)
Tenofovir 300mg qd + DWPUR001 Placebo bid
Placebo Comparator
Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of normalization of ALT level (≤1× ULN)(%)
时间窗: At the 4 weeks
次要结局
- The proportion of normalization of ALT level (≤1× ULN)(%)(At the 2, 8, 12, 24, 36, 48 weeks)
- The change of fibrosis marker(ELF score) compared with the baseline(At the 48 weeks)
- The change of HBV DNA level compared with baseline (IU/mL)(At the 12, 24, 36, 48 weeks)
- The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline(At the 12, 24, 48 weeks)
- The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)(At the 24, 48 weeks)
研究者
Chang Wook Kim
Professor
Uijeongbu St. Mary Hospital
研究点 (6)
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