EUCTR2014-001739-35-IT进行中（未招募）1 期
An Open-Label Study to Explore the Clinical Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant in HIV-HCV infected patients
niversità di Modena e ReggioEmilia0 个研究点目标入组 15 人开始时间: 2014年7月8日最近更新:
适应症
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
- 15
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.Males or females at least 18 years old at Screening. Subjects or their heterosexual partner(s) must either be of non-childbearing potential or they must use effective contraception from 2 weeks before the initiation of therapy until 6 months after the last dose of study medication.
- •2.HIV-HCV Co-infection documented with HIV-Ab and HCV RNA positivity
- •2.1Chronic HCV-infection, any genotypes, documented by at least one measurement of serum HCV RNA above the lower limit of quantification (LLoQ) measured during Screening
- •2.2 Chronic HIV infection undergoing antiretroviral therapy for at least 6 month with HIV Viral Load < 40 copies/ml
- •3. End stage Liver disease (ESLD) or HCC secondary to HCV meeting the MILAN criteria with a MELD between 15 and 35 and waiting list for OLT
- •4. Subjects must be naïve to treatment with NS5B polymerase inhibitors for chronic HCV infection.
- •5. A body mass index (BMI) of >=18 kg/m2.
- •6. Able to effectively communicate with the Investigator and other center personnel. Willing to give written informed consent and comply with the study restrictions and 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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any transplant patient who has agreed to a liver transplant from a live donor.
- •2. Patients requiring planned induction therapy with biologics post-transplantation or with a post-transplantation immunosuppressive regimen not consistent with:
- •o Solumedrol/Prednisone
- •o Tacrolimus (maintaining a serum level of 5-12 ng/mL)
- •3. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening and first dose.
- •4. Clinically significant ECG findings at screening, screening QTc = 500 ms (cirrhotic), or a personal or family history of Torsades de pointes
- •5. History of major organ transplantation with an existing functional graft.
- •6. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
- •7. Abnormal hematological and biochemical parameters, including:
- •a.neutrophil count <1000 cells/mm3
- •b. Hgb <8 g/dL without erythroid stimulating agents or blood transfusion
- •c. platelet count =10 000 cells/mm3
- •d. ALT or AST =10 times ULN
- •e. sodium <130 mmol/L
- •f. serum bilirubin > 30 mg/dL
- •g. serum albumin < 2.0 g/dL
- •8. History of clinically significant drug allergy to nucleoside/nucleotide analogs.
- •9. Participation in any other clinical trial within 3 months prior to screening visit and during the study
- •10. History of having received any systemic antineoplastic or immunomodulatory treatment (including radiation) within 3 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study (excluding a local regional therapy such as TACE).
- •11. Treatment with TACE or RFA within 30 days prior to the first dose.
- •12. Pregnant/Breastfeeding women or males whose partners are currently pregnant.
- •13. Poor venous access making the patient unable to complete the required laboratory testing schedule.
研究者
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