EUCTR2011-004724-35-IT进行中（未招募）不适用
Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects - REPLACE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •Male or female liver transplant recipient, 18 to 65 years old. 2. First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C and who is genotype 1 HCV RNA infected following transplantation. Genotype 1 must be confirmed during screening. 3. One of the following based on clinical history or by documented HCV RNA and treatment history: a) Treatment-naïve subject who did not receive any treatment with any approved or investigational medication or drug regimen for the treatment of HCV prior to liver transplantation; OR b) Treatment-experienced subject who received treatment for HCV prior to liver transplantation. Where documentation is available, treatment-experienced subjects who were treated with Peg-IFN/RBV and received 80% or more of the intended dose of Peg-IFN/RBV should be categorized based on their response as either: - Relapser: Subject had an undetectable HCV RNA level at the end of treatment (6 weeks or less after the last dose of medication) but did not achieve SVR; - Partial responder: Subject had a = 2 log10 decrease in HCV RNA at approximately Week 12 of previous therapy, but never achieved undetectable HCV RNA while on treatment; - Null responder: Subject failed to decrease HCV RNA by ? 2 log10 after approximately 12 weeks of therapy. 4. > 12 months to 10 years post-liver transplant. 5. Subject must be on a stable TAC or CsA containing immunosuppressive regimen defined as no change in immunosuppressive agents and dose for 3 months prior to the screening visit. Low-dose prednisone (average daily dose = 5 mg) being used as an immunosuppressant is allowed. Subject should not be on dual therapy with TAC and CsA, and combination treatment with mycophenolate mofetil (Cellcept) is not allowed. Subjects may not use any other immunosuppressive agents.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject is infected or co-infected with non-genotype 1 HCV. 2. Subject received treatment with a direct acting antiviral for hepatitis C. 3. Subject received HCV treatment (approved or investigational medication) following liver transplantation. 4. Subject has histological evidence of rejection on the most recent liver graft biopsy obtained at screening or within 3 months (no serial liver graft biopsies taken) to 6 months (if serial liver graft biopsies have been taken) prior to the screening visit. 5. Subject has a contraindication to the administration of Peg-IFN-alfa or RBV, including but not limited to any of the following: - hypersensitivity to Peg-IFN-alfa, RBV, or any of their components; - hemoglobinopathies (including thalassemia major, sickle-cell disease);history or clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent (within 1 year) myocardial infarction, significant arrhythmia), and/or clinically significant ECG abnormalities; - abnormal thyroid function that is not adequately controlled; - poorly controlled diabetes mellitus as evidenced by hemoglobin A1c (HbA1c) = 8.5% at screening; - antinuclear antibody (ANA) titer = 1:640 at screening, evidence of autoimmune-mediated disease (e.g., Crohn’s disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis), and/or evidence of autoimmune hepatitis.
研究者
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