A study of GS-7977 and Ribavirin in patients who have hepatitis C and have received a liver transplant

Conditions: Recurrent Chronic HCV Post Liver Transplant
MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-002417-19-DE

Lead Sponsor: Gilead Sciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Males or females, age = 18 years old
3. Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
4. HCV RNA = 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 = 6 months and = 150 months prior to screening
8. Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
9. A body mass index (BMI) of =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

Exclusion Criteria

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