EUCTR2004-001220-20-AT进行中（未招募）不适用
Efficacy and Safety of PEG-Intron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non Responder to Pegasys - Non-Responder Study
Integrated Therapeutics Group, Incorporated - a subsidiary of Schering-Plough0 个研究点目标入组 200 人开始时间: 2004年12月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •- 18-70 years of age
- •- Chronic Hepatitis C patients, non-responders to Pegasys/ribavirin treatment
- •- no other interferon treatment except Pegasys
- •- no other hepatitis C treatment
- •- TSH within normal limits
- •- Compensated liver disease with the following minimum hematologic and biochemical criteria at the Day 1 visit within normal limits:
- •Hemoglobin values of equal to or more than12 gm/dL for females and 13 gm/dL for males.
- •WBC equal to or more than 3,000/mm3
- •Neutrophil count equal to or more than 1,500/mm3
- •Platelet count equal to or more than 80,000/mm3
- •Direct bilirubin within normal limits
- •Indirect bilirubin within normal limits (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be less than or equal to 3.0 mg/dL (less than or equal to 51.3 µmol/L)
- •Albumin within normal limits
- •Serum creatinine within normal limits
- •Subject must be a non-responder, defined as having received and not having responded to a prior treatment consisting of one course of Pegasys 180 mcg QW in combination with ribavirin 1000-1200 mg daily for a minimum of 12 weeks and:
- •(a) Subject must be found to be HCV-RNA positive with less than a 2 log drop at 12 weeks of treatment
- •(b) is PCR positive at End Of Treatment whether End Of Treatment happened at week 48 or earlier
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant females
- •- subjects over 125kg
- •- Previously untreated subjects
- •- Subject discontinued from Pegasys due to adverse event
- •- Subject is co-infected with HIV and/or HBV
- •- Suspected hypersensitivity to interferon alpha or pegintron or ribavirin
- •- Subject has had organ transplants
- •- History of hepatocellular carcinoma, known coagulation disorders, G6PD deficiency, moderate to severe depression, craniocerebral trauma or active seizure disorders, cardiovascular dysfunction, chronic lung disease, immune-mediated disease, clinical gout, creatinine clearance less than 50 ml/min
- •- Subject needs use of chronic systemic steroids
- •- subject is active drug abuser.
研究者
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