EUCTR2011-000728-14-NL进行中（未招募）不适用
A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylate Administered with Ribavirin
Anadys Development, LTD0 个研究点目标入组 40 人开始时间: 2011年5月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female adults between 18 and 65 years of age, inclusive;
- •Patients should have chronic, documented, hepatitis C infection;
- •HCV genotype 1;
- •IL28B genotypic polymorphism CT;
- •Naïve to or have relapsed from prior pegylated interferon-alpha based therapy;
- •HCV RNA ³ 375,000 copies/mL or ³ 75,000 IU/mL;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •FFemale patients who are pregnant or who are breast-feeding;
- •For treatment naïve patients: any previous treatment for HCV infection;
- •For patients who relapsed after prior pegylated interferon + ribavirin treatment: previous treatment with an experimental therapy for HCV infection;
- •History of cirrhosis on prior liver biopsy;
- •History of biochemical or other signs of decompensated liver disease:
- •History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
- •History of alcohol abuse and/or other drug addiction < 1 year prior to enrollment in the study or, a positive drug screen for amphetamines or cocaine;
- •Poorly-controlled diabetes mellitus;
- •Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy;
- •History of seizure disorder;
- •History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, or psychosis requiring medication;
- •Medical condition that requires use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, or adrenal insufficiency); corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible;
- •Concurrent therapy with any immune-modulating agents, e.g., interleukins, interferons, vaccines, or immunosuppressive agents;
- •Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study;
- •One or more additional known primary or secondary causes of liver disease, other than hepatitis C;
- •Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations;
- •Any immunologically mediated disease (e.g., Crohn’s disease, ulcerative colitis);
- •History of a significant medical condition (except hepatitis C infection) that may interfere with the absorption, distribution, metabolism, or elimination of the study medication, or with the clinical and laboratory safety assessments in this study;
- •Malignancy within the last 5 years (squamous or basal cell skin cancers are allowed);
- •History of acute or chronic pancreatitis;
- •12-lead ECG showing Corrected QTc interval > 450 msec (Bazett’s correction), QRS > 120 msec, or Clinically significant abnormalities;
- •Donated or lost > 500 mL of blood < 30 days prior to enrollment into this study;
- •Participated in other clinical studies of a new chemical entity within 30 days prior to study randomization;
- •Active infection (cold, flu) within 14 days prior to the start of study or had a febrile illness within 5 days prior to administration of the first dose of study medication.
- •Any medical contraindications to Peg-INF or RBV therapy;
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