Health Condition 1: null- Adults with chronic HCV infection
Conditions
Interventions
Intervention1: Sofosbuvir (SOF)400mg/ velpatasvir (VEL)100mg is a Fixed Dose Combination: SOF/VEL tablet is to be administered once daily for 12 weeks with or without food.
Control Intervention1: Nil:
Sponsors
Gilead Sciences Inc
KlinEra Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: 1) Willing and able to provide written informed consent 2) Male or Female, Age >= 18 Years 3) HCV RNA detected at Screening 4) Chronic HCV infection (>=6 months) documented by medical history or liver biopsy 5)treatment naive or treatment experienced. Approximately 20% may be treatment-experienced. a) Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin b) Treatment experienced is defined as prior treatment failure to a regimen containing interferon either with or without RBV that was completed at least 8 weeks prior to Day 1. 6) Cirrhosis determination (approximately 20% may have cirrhosis) 7) Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment. 8) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. 9) Lactating females must agree to discontinue nursing before the study drug is administered 10) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1) Current or prior history of any of the following: a) Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol b) Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) c) Liver transplantation d) HCC (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with subject treatment, assessment or compliance with the protocol. 2) Any of the following laboratory parameters at screening: a) ALT > 10 ï?´ the upper limit of normal (ULN) b) AST > 10 ï?´ ULN c) Platelets d) Creatinine clearance (CLcr) {Cockcroft et al 1976} e) Hemoglobin 3) Prior exposure to HCV NS5A inhibitor 4) Pregnant female 5) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilsonâ??s disease, alfa-1 antitrypsin deficiency, cholangitis) 6) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 7) Active alcohol or drug abuse that would interfere with study participation. 8) Use of any prohibited concomitant medications as described in Section 5.3. 9) Known hypersensitivity to VEL, SOF, or formulation excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be evaluated using scheduled assessments of HCV RNA performed Timepoint: Screening,Baseline/Day1,and Week 12 (end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and laboratory tests will be collected throughout the study.Timepoint: SVR12 | — |
Countries
India
Contacts
Public ContactRajeev Singh
Klinera Corporation India
Outcome results
None listed