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

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.