EUCTR2009-009608-38-FR进行中（未招募）1 期
A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection
F.Hoffmann-La Roche0 个研究点目标入组 300 人开始时间: 2009年9月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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-naïve (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 pts w indeterminate or mixed subtypes will be allowed
- •2. History of having received any IMP = 3m prior to the 1st dose of study drug or the expectation that such drugs will be used during the study. Pts enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes Pts 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 excl
- •4. + 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
- •6. Females who are pregnant or breast feeding
- •7. Male partners of females who are pregnant
- •8. 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 pt w a baseline increased risk for anemia or for whom anemia would be medically problematic
- •12. Serum creatinine level > 1.5* 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 6m
- •14. Hist of severe psychiatric disease, incl 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 add, pts w a concurrent psychiatric condition or history of a psychiatric condition that, in the opinion of the Inv and/or Psychiatrist, would compromise participation in this study
- •15. Hist of immunologically mediated disease
- •17. Poorly controlled hypertension, with a hist 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. Hist or other evidence of chronic pulmonary disease associated with functional
- •20. Hist of severe cardiac disease. In add, pts w doc or presumed coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease should not be enrolled
- •21. Pts w higher potential for QTC prolongation; defined by QTC = 450 ms, or notable resting bradycardia < 50 beats/min, or notable resting tachycardia > 100 beats/min or personal or family history of congenital long QT syndrome or sudden death
- •22. Hist of uncontrolled severe seizure disorder
- •23. Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2y.
- •24. Hist of any systemic anti-neoplastic or immunomodulatory treatment (incl supraphysiologic doses of steroids and radiation) = 6m prior to the 1st dose of study drug or the expectation that such treatment will be needed at any time during the study
- •25. Poorly controlled thyroid dysfunction
- •26. Hist or other evidence of a clinically relevant ophthalmologic disorder due to
- •diabetes mellitus or hypertension or history /other evidence of severe retinopathy
- •27. Hist of major organ transplantation with an existing functional graft
- •28. Hist or other evidence
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