EUCTR2009-009608-38-IT进行中（未招募）不适用
A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in Combinationwith Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Na?ve Patients with Chronic Hepatitis C Genotype 1 Virus Infection. - ND
F.Hoffmann-La Roche0 个研究点目标入组 300 人开始时间: 2009年9月7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
- 300
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
- •1. Age 18 years and older;
- •2. Serologic evidence of CHC infection by an anti-HCV antibody test (current or historical);
- •3. Evidence of chronic hepatitis C infection > 6 months duration;
- •4. Evidence of hepatitis C genotype 1 infection by molecular assay;
- •5. Serum HCV RNA quantifiable at ≥ 50,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test;
- •6. HCV treatment-na?ve (i.e. have never received treatment for CHC, including but not limited to IFN-based therapy, ribavirin, or other anti-viral agents with established or
- •perceived activity against the HCV virus);
- •7. Liver biopsy within the past 24 months showing clear absence of advanced fibrosis or cirrhosis (as indicated in Appendix 1). Liver biopsy should be scored using one of
- •the scoring methods in Appendix 1;
- •8. Normal cardiac troponin I (cTnI) value at the screening visit (< 0.100 ng/mL);
- •9. Serum total bilirubin value at the screening visit within the reference range;
- •10. Negative urine pregnancy test (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs confirmed by a negative serum pregnancy test collected within 24 hours prior to the first dose of
- •study drug. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and following the last dose of RBV in
- •accordance with locally approved label for RBV;
- •11. Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
- •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
- •1. Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype. Genotype 1 patients with indeterminate or mixed subtypes will be allowed
- •(for example, genotype 1a/b);
- •2. History of having received any investigational drug ≤ 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes; 3. Patients who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are
- •also excluded; 4. Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab;
- •5. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, Wilsons disease,
- •α1-antitrypsin deficiency, metabolic liver disease, alcoholic liver disease, and/or toxin exposure);
- •6. Females who are pregnant or breast feeding; 7. Male partners of females who are pregnant; 8. Body mass index (BMI) < 18 or ≥ 36; 9. Absolute neutrophil count (ANC) < 1.5 x 103 / μL (< 1.5 x 109 /L); 10. Platelet count < 90 x 103 / μL (< 90 x 109 /L);
- •11. Hemoglobin (Hgb) concentration < 11 g/dL (< 110 g/L) in females or < 12 g/dL (< 120 g/L)in males or any patient with a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or
- •for whom anemia would be medically problematic; 12. Serum creatinine level > 1.5 times the upper limit of normal at screening; 13. The use of colony stimulating factors such as granulocyte colony stimulating factor
- •(G-CSF), erythropoietin, blood transfusion or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within the last
- •6 months; 14. History of severe psychiatric disease, including psychosis and/or severe depression,
- •characterized by a suicide attempt, hospitalization for psychiatric disease, or a period
- •of disability as a result of psychiatric disease. In addition, patients with a concurrent
- •psychiatric condition or history of a psychiatric condition that, in the opinion of the Investigator and/or Psychiatrist, would compromise participation in this study;
- •15. History of immunologically mediated disease (e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined
- •as affecting > 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management, etc); 16. History or other evidence of decompensated liver disease. Coagulopathy,
- •hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease; 17. Poorly controlled hypertension, with a history of poor adherence to antihypertensive therapy or screening or baseline blood pressure of systolic ≥ 160 mmHg and/or
- •diastolic ≥100 mmHg; 18. Type I or II diabetes with HbA1C > 8.5% at the Screening Visit; 19. History or other evidence of chronic pulmonary disease associated with functional limitatio
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