A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 weeks in Subjects with Recurrent Chronic HCV Post Liver Transplant

Gilead Sciences Inc0 个研究点目标入组 40 人开始时间: 2012年9月14日最近更新: 2015年2月2日

适应症

试验速览

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•1. Willing and able to provide written informed consent
•2. Males or females, age > or = 18 years old
•3. Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
•4. HCV RNA > or = 10000 IU/mL at screening
•5. Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to Baseline/Day 1 visit
•6. Primary or secondary (retransplant), liver alone or liver and kidney transplant recipient from deceased or living donor (regardless of the HCV status of the liver donor)
•7. Liver transplant > or = 6 months and < or = 150 months prior to screening
•8. Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
•9. A body mass index (BMI) of > or = 18 kg/m2
•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 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. Multi-organ transplant that includes heart or lung recipient
•2. Subjects with de novo or recurrent Hepatocellular Carcinoma (HCC) post transplant based on center specific screening protocol
•3. Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
•4. Child-Pugh-Turcotte Score CPT > 7 at screening
•5. MELD score > 17 at screening
•6. Recipient of ABO incompatible organ
•7. Histological evidence of unresolved rejection
•8. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) at screening
•9. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
•10. Serum creatinine >2.5x upper limit of normal or stage 4 chronic kidney disease (CrCl <30ml/min)
•18. Treatment with IFN, RBV, telaprevir or boceprevir or any other approved or experimental medication with known anti-HCV activity within 3 months prior to Baseline/Day 1 visit
•19. Screening ECG with clinically significant abnormalities
•20. Participation in a clinical study with an investigational drug, or biologic within 3 months prior to first dose administration at the Baseline/Day 1 Visit

发起方