Chronic Hepatitis C virus infection MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0 Level: PT Classification code 10019754 Term: Hepatitis cholestatic System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: sofosbuvir/velpatasvir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sofosbuvir
CAS Number: 1190307-88-0
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Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Willing and able to provide written informed consent 2) Males and females, age = 18 years old 3) Chronic HCV infection (=6 months) documented pretransplantation by prior medical history or liver biopsy 4) HCV RNA = 104 IU/mL at screening 5) No clinical signs of rejection for 3 months prior to the Screening visit 6) Primary or secondary (re-transplant), 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 = 3 months prior to screening 8) A body mass index (BMI) of = 18 kg/m2 9) Subjects must have a determination of treatment experience (see protocol for details). 10) Subjects must have appropriate testing for determination of cirrhosis status (see protocol for details). 11) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic subjects only to exclude hepatocellular carcinoma (HCC) 12) A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal) 13) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 14) Lactating females must agree to discontinue nursing before the study drug is administered 15) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Multi-organ transplant that includes heart or lung recipient (patients who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll) 2) Subjects with de novo or recurrent Hepatocellular Carcinoma (HCC) posttransplant 3) Current use of corticosteroids at any dose >5mg of prednisone/day (or equivalent dose of corticosteroid) 4) Child-Pugh-Turcotte (CPT) Score >7 at Screening 5) Recipient of ABO incompatible organ 6) Histological evidence of unresolved rejection 7) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) at Screening 8) Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis 9) Serum creatinine >2.5x upper limit of normal (ULN) or stage 4 chronic kidney disease (CrCl300mg/day,or use of any prohibited medications listed in Section 5.4 within 28 days of the Baseline/Day 1 visit 16) Prior exposure to any HCV NS5A inhibitor 17) History or current evidence of immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, porphyria, seizure disorder, poorly controlled diabetes, pancreatitis with elevated lipase, cancer, or a history of malignancy (with exception of certain resolved skin cancers or pre-transplant hepatocellular carcinoma; patients who received liver transplants for hepatocellular carcinoma must be 5 years post-transplant with no evidence of recurrence at Screening) that in the opinion of the investigator makes the subject unsuitable for the study 18) Treatment for HCV infection with experimental or approved regimens within 3 months of Baseline/Day 1. 19) Participation in a clinical study with an investigational drug, or biologic within 3 months prior to Baseline/Day 1 20) Clinically relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by prescribed medications; the diagnosis and prescription must be approved by the investigator 21) History or difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 22) Known hypersensitivity to SOF (and the metabolites), and/or VEL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of study treatment regimen) in the Full Analysis Set (FAS). The primary safety endpoint is any AE that led to permanent discontinuation of study drug. ;Timepoint(s) of evaluation of this end point: The safety and tolerability endpoints are evaluated during the course of treatment. The efficacy endpoint is evaluated 12 weeks after discontinuation of therapy.; Main Objective: To evaluate the efficacy of study treatment with sofosbuvir (SOF)/velpatasvir (VEL) FDC for 12 weeks as measured by the proportion of subjects with sustained virologic response 12 weeks after cessation of study treatment regimen (SVR12) To evaluate the safety and tolerability of the study treatment regimen ; Secondary Objective: To determine the proportion of subjects who attain SVR at 4 weeks after cessation of the study treatment regimen (SVR4) To evaluate the kinetics of circulating HCV RNA during study treatment and after cessation of study treatment regimen To evaluate the emergence of viral resistance to SOF and VEL during study treatment and after cessation of study treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The efficacy endpoints are evaluated 4 weeks after discontinuation of therapy. The other endpoints are evaluated during the course of treatment.;Secondary end point(s): The secondary efficacy endpoints include the proportion of subjects who attain sustained virologic response at 4 weeks after cessation of the study treatment regimen (SVR4); the proportion of subjects who have HCV RNA < LLOQ by visit while on study treatment; absolute and change from baseline/Day 1 in HCV RNA through Week 12; and the proportion of subjects with virologic failure. | — |
Countries
Spain, Switzerland, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed