EUCTR2011-004129-28-SK进行中（未招募）不适用
Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR in Combination With Peginterferon Alfa-2a Plus Ribavirin in Treatment-naive Patients and with addition of RO5024048 in Previous Null Responder Patients With Chronic Hepatitis C Genotype 1 or 4 and Compensated Cirrhosis.
F. Hoffmann-La Roche0 个研究点开始时间: 2011年12月6日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Gender : Male and Female
- •History of CHC GT 1 or GT 4, documented with HCV genotype and serum HCV RNA of > 1 x 105 IU/mL at Screening.
- •HCV-treatment-naive Cohort 1 (ie, have never received treatment for their condition including but not limited to IFN-based therapy, RBV, or other anti-viral agents with established or perceived activity against HCV).
- •HCV prior P/R null responders for Cohort 2. Documentation of previous treatment failure after starting treatment with approved doses of PEG-IFN plus RBV. Patients must have been adherent to previous therapy and have taken a minimum of approximately 80% of the previous course of therapy for a least the first 12 weeks as estimated by the investigator in consultation with the patients and must have failed treatment as a consequence of null virologic response (<2 log 10 reduction in HCV RNA at week 12).
- •Liver biopsy confirming cirrhosis: Knodell score = 4, Metavir score = 4, Batts & Ludwig score = 4, or Ishak modified HAI score = 5
- •Compensated cirrhosis (Child-Pugh A)
- •Patients must have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 6 months prior to Screening), and a serum alfa-fetoprotein (AFP) <100ng/mL (< 100 µg/L at Screening).
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices).
- •For Cohort 2: Patients who discontinued previous P/R therapy due to reasons other than null response (eg, intolerability, lost to follow up, noncompliance).
- •Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, alfa-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson’s disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy.
- •Positive Hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) antibody at Screening.
- •Use of blood transfusion growth factors (including, but not limited to, granulocyte colony stimulating factor or erythropoietin) or any other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within 3 months before Screening
- •History of severe psychiatric disease
- •Laboratory parameters: ALT > 10x ULN; Bi =1.5x ULN; serum amylase or lipase > 1.5 x ULN; Hgb < 12- g/L (males), < 120 g/L (females): HA1c =8.5;CrCl < 70 mL/min, microproteinuria and Uprotein/Cr ratio = 0.3 (33.89 mg/mmoL; ANC = 1500 /µL; platelets = 90,000/µL
研究者
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