NCT02289300撤回2 期
A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Study of DCB-BO1202 for Alleviating Liver Fibrosis in HBV Patients With Intermediate Hepatocellular Carcinoma Receiving Loco-regional Therapies
A2 Healthcare Taiwan Corporation1 个研究点 分布在 1 个国家开始时间: 2020年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
研究概览
简要总结
The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)
详细描述
The study will include the first 188 subjects who are randomized. The purpose of study is to collect efficacy results to evaluate treatment effect on the primary endpoint. The second endpoints is to evaluate drug safety on the incidence of the primary endpoint through the treatment 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-65 years (inclusive) of either gender
- •With evidence of HBV infection confirmed by positive for Hepatitis B virus antigen (HBsAg)
- •With Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC-B) hepatocellular carcinoma (HCC)
- •Having received radiofrequency ablation (RFA) or transarterial embolization (TAE) for hepatitis B virus (HBV) related hepatocellular carcinoma at least 4 weeks before Screening
- •With liver stiffness measurement (assessed by Fibroscan®) of 7-20 kPa
- •Able to understand and willing to sign the informed consent
排除标准
- •Evidence or history of chronic hepatitis caused by Hepatitis C virus (HCV)
- •With abnormal organ functions such as absolute neutrophil count (ANC) < 1500 /μL, hemoglobin < 9 gm/dL, platelets < 50,000 /μL, creatinine > 2 mg/dL, alanine aminotransferase (AST) or ALT > 5 X upper normal limit of the current institution; bilirubin > 2.5 mg/dL, prothrombin time (PT) prolongation > 4 sec above upper limit of normal
- •With uncontrolled infection or serious infection within the past 4 weeks
- •With any other carcinoma except skin cancer
- •Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
- •Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
- •History of allergy to any substance of investigational products
- •With known human immunodeficiency virus (HIV) infection
- •Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- •With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- •Administered with any anti-HBV drugs within 4 weeks of entering this study. (Note: Anti-HBV treatments are allowed to be taken during study period when necessary.)
- •Having participated other investigational study within 4 weeks of entering this study
研究组 & 干预措施
DCB-BO1202
Experimental
干预措施: DCB-BO1202 (Drug)
DCB-BO1202+Placebo
Experimental
干预措施: DCB-BO1202+Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
时间窗: 96 weeks
次要结局
- Recurrence rate at Week-96 visit(Week 96)
- Time to recurrence of cancer(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Incidence of adverse events (AEs)(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84)
- Changes from baseline in biomarkers associated with liver fibrosis at each post-treatment visit compared to baseline(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Changes from baseline in hepatic functions such as liver enzymes, albumin, direct bilirubin and international normalize ratio (INR) at each post-treatment visit compared to baseline(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Change from baseline in log10 HBV deoxyribonucleic acid (DNA) measured by Polymerase chain reaction (PCR) assay at each post-treatment visit and each of post-study follow-up visits compared to baseline(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Transition of HBV DNA detectable status (e.g. <500 copies/mL) by PCR at each post-treatment visit from baseline(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue total score and sub-scores compared to baseline at each post-treatment visit(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
- Overall survival rates at Week-48 and Week-96 visits(Weeks 48, 96)
- Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results(Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96)
研究者
研究点 (1)
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