NCT00570336已完成2 期
A Dose Response Study of CTS-1027 in Hepatitis C Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 19
- 主要终点
- Number of adverse events at each dose level
研究概览
简要总结
The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection.
详细描述
Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, administered orally once daily, in outpatients with chronic hepatitis C virus (HCV) infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
- •A history of chronic HCV infection
- •Unsuccessful HCV treatment defined as one or more of the following criteria:
- •Failure to achieve a virologic response during previous therapy, or
- •Failure to tolerate therapy, or
- •Failure to maintain a sustained virologic response, or
- •In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon based therapy
- •Liver impairment, as defined by either aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels 1.5 - 7 x ULN on at least two occasions, seven or more days apart, during the baseline period
- •Alpha-fetoprotein (AFP) <= 50 ng/mL
- •Hemoglobin >= 10 g/dL, platelet count >= 75 x 109/L, and white blood cell count >= 1.5 x 109/L
- •Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month after the completion of the trial.
排除标准
- •Decompensated or severe liver disease defined by one or more of the following criteria:
- •Prior liver biopsy showing cirrhosis
- •Prior liver biopsy showing bridging fibrosis (Metavir >2 or Ishak >3) more than 2 years ago in the absence of newer liver biopsy results
- •Prothrombin time: 3 seconds > control
- •Total bilirubin >= 1.5 x Upper limit of the normal range (ULN), or > 3 x ULN for unconjugated bilirubin
- •Serum albumin below normal limits
- •AST or ALT > 7 x ULN during baseline period
- •Evidence of portal hypertension including:
- •Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound,
- •Varices in esophagogastroduodenoscopy (EGD); or
- •Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
- •Known history or presence of human immunodeficiency virus (HIV) infection
- •Co-infection with hepatitis B virus (HBV)
- •If female: pregnant, lactating, or positive serum or urine pregnancy test
- •Last baseline AST and ALT level prior to Day 1 of < 1.5 x ULN
- •Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome
- •Pancreatitis
- •Hospitalization for liver disease within 60 days of screening
- •Use of concomitant or prior drug therapy for HCV at screening, including the use of:
- •drugs with presumed anti-HCV activity in the prior three months
- •corticosteroids in the past 30 days
- •potentially hepatotoxic drugs in the past 30 days (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
- •Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
- •History of alcohol abuse within the past year
- •History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of > 450 milliseconds
- •Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
- •Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.
研究组 & 干预措施
2.5 milligram (mg) CTS-1027
Experimental
2.5 mg CTS-1027
干预措施: CTS-1027 (Drug)
5 mg CTS-1027
Experimental
5 mg CTS-1027
干预措施: CTS-1027 (Drug)
10 mg CTS-1027
Experimental
10 mg CTS-1027
干预措施: CTS-1027 (Drug)
30 mg CTS-1027
Experimental
30 mg CTS-1027
干预措施: CTS-1027 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of adverse events at each dose level
时间窗: 4 to 24 weeks
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels at each dose
时间窗: 4-24 Weeks
次要结局
- Peak and trough levels of CTS-1027 in plasma(4 to 24 weeks)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
2 期
CTS-1027 in Interferon-Naive Hepatitis C PatientsHepatitis CNCT00925990Conatus Pharmaceuticals Inc.70
已完成
2 期
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)Hepatitis C, ChronicHepatitis CNCT00787371Merck Sharp & Dohme LLC69
已完成
不适用
Hepatitis C Rimantadine and Antiviral Combination TherapyHepatitis CNCT01413490The Leeds Teaching Hospitals NHS Trust10
终止
2 期
Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis CHepatitis CThrombocytopeniaNCT01821625University of Texas Southwestern Medical Center7
已完成
2 期
Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCVHepatitis C, ChronicNCT00863239Biolex Therapeutics, Inc.116