Daclatasvir plus Sofosbuvir for chronic HCV-infected renal transplant patients – a pilot study of efficacy and safety

Charité Universitätsmedizin Berlin0 个研究点开始时间: 2015年8月28日最近更新: 2015年12月7日

试验速览

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•1. >18 year old renal transplant recipients
•2. Renal transplant patients with chronic HCV-infection, Genotyp Ia and Ib with HCV RNA
•3. Renal transplant patients with untreated or previously failed treatment of HCV-infection
•4. Renal transplant patients with calculated glomerular filtration rate (cGFR) according to the CKD-EPI formula >30ml/min
•5. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
•6. Women of childbearing potential (WOCBP) should have a negative pregnancy test (serum or urine) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•1. WOCBP who is either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
•2. Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
•3. Treatment with any investigational drug within 3 months preceding the study
•4. Patient with a history of malignancies in the last 5 years with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
•5. Patients with Co-infection with HIV or HBV
•6. Patients with evidence of a medical condition associated with chronic decompensated liver disease (Child-Pugh class B or C)
•7. Patients who suffered from severe rejection (= Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrolment in this study.

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