A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 21
- 主要终点
- Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
研究概览
简要总结
The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.
详细描述
There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.
This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.
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 (> 6 months duration) genotype 1 Hepatitis C (HCV) infection
- •Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:
- •Contra-indicated for interferon treatment due to current or prior psychiatric disorders
- •Patient's decision to not pursue interferon-based therapy
- •In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon-based therapy
- •a-fetoprotein (AFP) <= 50 ng/mL
- •Hemoglobin ≥ 12 g/dL, platelet count ≥ 100 x 109/L, and white blood cell count ≥ 1.5 x 109/L
- •Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.
排除标准
- •Decompensated or severe liver disease defined by one or more of the following criteria:
- •Prothrombin time 3 seconds > control
- •Direct bilirubin ≥ 1.5 x upper limit of normal range (ULN)
- •Serum albumin below normal limits
- •AST or ALT > 7 x ULN at screening
- •Evidence of portal hypertension including:
- •Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
- •Cirrhosis defined by one or both of the following criteria:
- •Liver biopsy showing cirrhosis
- •Other clinical signs and symptoms suggestive of cirrhosis
- •Prior therapy for HCV with an interferon-based regimen
- •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 pregnancy test
- •Renal impairment (creatinine > 1.5 x ULN), creatinine clearance < 50 mL/min, or hepatorenal syndrome
- •Hospitalization for liver disease within 60 days of screening
- •Use of concomitant or prior drug therapy for HCV three months prior to screening
- •Use of drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
- •History of alcohol abuse (> 50 g per day) 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
CTS-1027 + ribavirin
Study drug plus ribavirin
干预措施: ribavirin (Drug)
CTS-1027 + ribavirin
Study drug plus ribavirin
干预措施: CTS-1027 (Drug)
CTS-1027 + placebo
Study drug plus placebo for ribavirin
干预措施: CTS-1027 (Drug)
CTS-1027 + placebo
Study drug plus placebo for ribavirin
干预措施: Placebo for ribavirin (Drug)
结局指标
主要结局
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
时间窗: Baseline and 24 weeks
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
次要结局
- Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment(Baseline and 24 weeks)