EUCTR2008-000533-22-ES进行中（未招募）1 期
Ensayo en fase III, aleatorizado, doble ciego, controlado con placebo, de dos regímenes de telaprevir (con y sin comienzo retrasado) combinado con interferón pegilado alfa 2a (Pegasys®) y ribavirina (Copegus®) en sujetos con infección de hepatitis C crónica genotipo 1, que fracasaron tratamiento previo con interferón pegilado y ribavirina.A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment. - REALIZE
Tibotec BVBA0 个研究点目标入组 0 人开始时间: 2008年8月25日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 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
- •Subjects who meet all of the following criteria are eligible for this trial:
- •1. Subject is male or female, 18 to 70 years of age, inclusive.
- •2. Subject has chronic hepatitis C infection genotype 1 with HCV RNA level = 1000 IU/mL. Genotype must be confirmed during screening. Chronic infection status must be confirmed by diagnosis of HCV > 6 months before the screening period.
- •3. Subject failed at least 1 prior course of Peg-IFN/RBV therapy, defined as:
- •- Subject had an undetectable HCV RNA level (by branched-chain DNA [bDNA], reverse transcription-polymerase chain reaction [RT-PCR], or transcription mediated amplification [TMA]-based assay) at the end (6 weeks or less after the last dose of medication) of a prior course of at least 42 weeks of Peg-IFN/RBV therapy but did not
- •achieve SVR (viral relapser); or
- •- Subject never had an undetectable HCV RNA level (by bDNA, RT-PCR, or TMA-based
- •assay) during or at the end of a prior course of at least 12 weeks of Peg-IFN/RBV therapy (null-responder and partial responder). Subject must have received 80% or more of the intended dose of Peg-IFN/RBV. The following information related to the virologic response to the last course of Peg-IFN/RBV therapy (that qualifies as an adequate course as defined above) must be available in the medical records of the subject:
- •- start and end date of the previous treatment course;
- •- HCV RNA values at start of treatment (all subjects), at 12 weeks after start of treatment (all subjects), at end of treatment (all subjects), and during follow-up (relapsers);
- •Note: the following time window is allowed for the Week 12 assessment time
- •point: Week 11 to Week 16
- •- HCV RNA assay used and limit of detection.
- •4. Subject must have received the last dose of Peg-IFN or RBV at least 12 weeks before the screening visit.
- •5. Subject is judged to be in good health (besides HCV infection) in the opinion of the
- •investigator, on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ECG]), with any chronic medical conditions under stable medical control.
- •6. Subject must have had a liver biopsy within 18 months prior to the screening visit and the biopsy report should be available, or he/she should agree to have a biopsy performed within the screening period.
- •Note: If a biopsy more than 18 months prior to screening has already demonstrated
- •histological cirrhosis (Metavir F4; Ishak score = 5), the biopsy does not need to be repeated if the biopsy report can be provided.
- •7. Subjects with cirrhosis should have serum alpha-fetoprotein (AFP) = 50 ng/mL and normal abdominal ultrasound. If AFP > 50 ng/mL or ultrasound abnormal, subjects must have a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan to exclude hepatocellular carcinoma.
- •8. If heterosexually active, a female subject of childbearing potential and a non- asectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV.
- •Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, to be eligible for this trial, subjects should use 2 other effective birth control methods during telaprevir/placebo treatment and for 2 months after the last intake of telaprevir/placebo. As of 2 months after completion of telaprevir/placebo treatment, hormonal contraceptives can
排除标准
- •Subjects meeting one or more of the following criteria cannot be selected:
- •1. Subject is a previous non-responder that is classified as a viral breakthrough case i.e., subject had an undetectable HCV RNA level (by bDNA, RT-PCR, or TMA-based assay) during prior course of Peg-IFN/RBV therapy but regained detectable HCV RNA before therapy ended.
- •2. Subject is infected with HCV genotype 1 exhibiting more than one subtype.
- •3. Subject has HCV genotype 1 and exhibits co-infection with any other genotype.
- •4. Subject discontinued prior course(s) of Peg-IFN/RBV therapy due to a tolerance issue instead of lack of response.
- •5. Subject has any contraindication to the administration of Peg-IFN alfa-2a or RBV, including but not limited to any of the following:
- •- hypersensitivity to Peg-IFN alfa-2a, RBV, or any of their components;
- •- hemoglobinopathies (including thalassemia major, sickle-cell disease);
- •- history or clinical evidence of significant or unstable cardiac disease and/or
- •clinically significant ECG abnormalities;
- •- abnormal thyroid function that cannot be controlled effectively by medication;
- •- poorly controlled diabetes mellitus as evidenced by HbA1C = 8.5% at screening;
- •- creatinine clearance = 50 mL/min at screening;
- •- antinuclear antibody (ANA) titer = 1:640 at screening, evidence of
- •autoimmune-mediated disease and/or evidence of autoimmune hepatitis.
- •6. Subject has a pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the trial, including but not limited to:
- •- severe depression or hospitalization for depression;
- •- schizophrenia, bipolar illness, severe anxiety, or personality disorder;
- •- a period of disability or impairment due to a psychiatric disease within the past 5 years.
- •7. Subject has history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
- •- International Normalized Ratio (INR) of = 1.5;
- •- Serum albumin < 3.3 g/dL;
- •- Serum total bilirubin > 1.8 times ULN, unless isolated and for subjects with Gilbert’s
- •8. Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, Nonalcoholic Steatohepatitis (NASH), or primary biliary cirrhosis.
- •9. Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
- •10. Subject has history of seizure disorders.
- •11. Subject has history of organ transplant that requires chronic immunosuppression
- •12. Subject has a medical condition that requires use of systemic corticosteroids
- •13. Diabetic or hypertensive subject with clinically significant ocular exam findings, e.g., retinopathy, cotton wool spots, and optic nerve disorder.
- •14. Subject has history or other clinical evidence of chronic pulmonary disease associated with functional impairment.
- •15. Subject has hemophilia.
- •16. Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
- •17. Subject has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co- infection.
- •18. Subject has a history of acute or chronic pancreatitis.
- •19. Suspicion exists of alcohol, barbiturate, amphetamine recreational or narcotic drug use, current or within 2 years prior to the screening visit, that in the
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