NCT00759200已完成2 期
An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 525
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
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
- None
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
- •Age of 18 years or older
- •Clinical diagnosis of chronic hepatitis C
- •Infection with HCV genotype 2 or 3
- •No previous IFNα-based therapy
排除标准
- •Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
- •Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
- •History or current evidence of decompensated liver disease; other forms of liver disease
- •Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •History of moderate, severe or uncontrolled psychiatric disease
- •History of seizure disorder
- •History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
- •Clinically significant findings on eye/retinal examination
- •History of immunologically mediated disease
- •Organ transplantation other than cornea or hair transplant
- •History of clinically significant hemoglobinopathy
- •Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
- •History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
- •Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit
- •Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
- •Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
- •Have a clinically significant laboratory abnormality
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
alb-interferon arm 1
Experimental
干预措施: alb-interferon alfa 2b (Drug)
alb-interferon arm 2
Experimental
干预措施: alb-interferon alfa 2b (Drug)
alb-interferon arm 3
Experimental
干预措施: alb-interferon alfa 2b (Drug)
alb-interferon arm 4
Experimental
干预措施: alb-interferon alfa 2b (Drug)
peg-interferon
Active Comparator
干预措施: peg-interferon (Drug)
结局指标
主要结局
Adverse events
时间窗: at every visit
次要结局
- Viral load(at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.)
研究者
研究点 (2)
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