A study of GS-7977 and Ribavirin in patients with HCV waiting for a liver transplant

Conditions: MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Hepatitis C Virus (HCV) infection (all genotypes) in patients who have been placed on a wait list for liver transplantation from a deceased doner for hepatocellular carcinoma (HCC).
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-000637-39-ES

Lead Sponsor: Gilead Sciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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. Confirmation of chronic HCV infection
4. HCV RNA > 104 IU/mL at Screening
5. Patients meeting the MILAN criteria undergoing liver transplant for HCC secondary to HCV with a MELD of <22 and a HCC weighted MELD of ?22.
6. Child-Pugh Score (CPT) ? 7
7. Planned management of the subject to meet UNOS criteria, with imaging studies made available for review if required
8. A body mass index (BMI) of ?18 kg/m2.
9. Screening ECG without significant clinical abnormalities with a QTc ? 500 ms with no personal or family history of Torsades de pointes
11. Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
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. Prior exposure to a direct-acting antiviral targeting the HCV NS5b polymerase
2. Any transplant patient who has agreed to a liver transplant from a live donor
3. Subjects requiring planned induction therapy with biologics post-transplantation or with a post-transplantation immunosuppressive regimen
4. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome, among other signs of decompensated cirrhosis
5. Recent (within 4 weeks of screening) episode of infection requiring systemic antibiotics
6. Pregnant or nursing female or male with pregnant female partner
7. Chronic liver disease of a non-HCV etiology
8. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
9. Contraindications to RBV therapy
10. History of malignancy diagnosed or treated within 5 years
11. History of clinically significant hemoglobinopathy
12. Chronic use of systemically administered immunosuppressive agents
13. History of previous solid organ transplantation
14. Evidence of renal impairment