NCT02293941终止2 期
A Phase 2, Randomized, Multiple-dose, Double-blind, Placebo-controlled Study of JKB-122 to Assess Liver Tests in HCV Subjects Who Have Been Nonresponsive to Prior Interferon Based Therapies Either Alone or in Combination With Ribavirin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 14
- 主要终点
- ALT
研究概览
简要总结
The primary objective of this study is to assess changes in alanine aminotransferase (ALT) in hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who have been nonresponsive to, intolerable to, or relapsed from prior interferon-based therapies (pegylated or standard) either alone or in combination with ribavirin or other anti-HCV therapies including direct-acting anti-viral agents.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is HCV positive (documented by HCV RNA testing at Screening). Chronic hepatitis C is defined as a) Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening; or b) Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis), according to "Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment".
- •Has previous results from HCV genotype testing. If previous results are not available, such testing should be performed at Screening.
- •Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:
- •Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results
- •ALT and AST values not exceeding 5 x ULN (Baseline value for each parameter will be calculated as the average of 3 values obtained 7 days apart
- •Normal total bilirubin, and prothrombin time/INR values
- •Has elevated liver test results (ALT) at least 1.5 x ULN and not exceeding 5 x ULN (Baseline value for each parameter will be calculated as the average of 3 values obtained 7 days apart
- •Is refractory or null responder, intolerable, relapser, or partial responder.
- •Null responder is defined as less than a 2 log10 IU/mL reduction in HCV RNA after 12 weeks of treatment with standard or Peg Interferon/ribavirin or other anti-HCV therapies;
- •Relapser is defined as HCV RNA undetectable (or negative, per site's definition) at the end stage of treatment with a standard or pegylated interferon-based regimen or other anti-HCV therapies, but HCV RNA detectable during post-treatment follow-up;
- •The intolerable is defined as HCV patients who cannot tolerate the side effects of previous interferon-based therapies or other anti-HCV therapies, or who were not suitable for interferon-based therapies or other anti-HCV therapies;
- •Partial responder is defined as achieved more than 2 log10 IU/mL reduction in HCV RNA by Week 12 (± 1 week) during a prior pegIFN/RBV treatment course or other anti-HCV therapies but failed to achieve HCV RNA undetectable at the end stage of treatment.
排除标准
- •Has history of allergy to JKB-122 or related compounds
- •Has human immunodeficiency virus (HIV) or is hepatitis B positive
- •Is with a current diagnosis of cirrhosis, both compensated and uncompensated Child-Pugh A, B or C
- •Has positive urine drug screen at Screening
- •Is currently consuming greater than 30 g of alcohol per day (eg, 2 highballs with 1 shot each, or 2 beers) or has consumed greater than 2 glasses of alcohol per day within 3 months prior to the first screening visit (Day -28)
- •Is being treated with any prescription narcotic drug (including transdermal delivery systems)
- •Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
- •Has unstable and uncontrollable hypertension (>180/110 mmHg)
- •Has received other therapies for HCV infection (interferon, pegylated interferon, ribavirin, or others) in the last 4 weeks prior to the first screening visit (Day -28)
- •Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications
- •Has received other investigational agents within 30 days prior to the first screening visit (Day -28)
- •Has a disease that would require chronic use of prescription corticosteroids
- •Has either autoimmune or genetic liver disease
- •May be chronically or latently infected with microbial agents other than HCV
- •Has impaired renal function
- •Has BMI> 30 or BMI <18
- •If female, pregnant or lactating
研究组 & 干预措施
JKB-122 5mg
Experimental
5mg, oral, once daily
干预措施: JKB-122 5mg (Drug)
JKB-122 15 mg
Experimental
15mg, oral, once daily
干预措施: JKB-122 15mg (Drug)
JKB-122 35 mg
Experimental
35mg, oral, once daily
干预措施: JKB-122 35mg (Drug)
placebo
Placebo Comparator
comparable capsule, oral, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
ALT
时间窗: baseline and 12 weeks
To assess changes in ALT in HCV-infected subjects given daily doses of JKB-122
次要结局
- Pharmacokinetic analysis (plasma concentration of JKB-122)(Day 1, 29, 57, 78)
- Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.)(Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS)
研究者
研究点 (14)
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