Chronic Hepatitis C virus infection MedDRA version: 17.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Harvoni 90 mg/400 mg film-coated tablets
Product Name: Harvoni
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Current Sponsor code: GS-797
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements. Subjects will provide assent if possible. 2. 3 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating subjects 2. Sexually-active males or females of childbearing potential who are not willing to use an effective method of contraception during the study 3. Decompensated liver disease 4. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency) 5. alpha-fetoprotein > 50 ng/mL 6. Serum creatinine > 1.5 mg/dL 7. Estimated glomerular filtration rate 2 weeks (pulmonary/nasal administration is permitted) 15. Investigational agents taken within the past 28 days (except with the expressed approval of the Sponsor) 16. Clinically-relevant alcohol or drug abuse within 12 months of screening. 17. Known hypersensitivity to the study drugs, the metabolites, or formulation excipients 18. Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements 19. Use of any prohibited concomitant medications 20. PK Lead-in only: subjects with history of cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - For the PK Lead-in Phase, the appropriateness of the LDV/SOF FDC dose will be assessed by evaluating the steady-state PK of the LDV/SOF FDC. The primary endpoint for determining steady state PK is AUCtau of GS-331007, SOF, and LDV. Additional steady-state PK parameters of GS-331007, SOF, and LDV (e.g., AUClast, Cmax, Tmax, Clast, Tlast, Ctau, ?z, CL/F, Vz/F and t½) will be estimated and summarized.. - For the Treatment Phase, the primary safety endpoint is any AE leading to permanent discontinuation of study drug (s).;Timepoint(s) of evaluation of this end point: - In the PK lead in phase 12 weeks data will be collected at screening Day1, Day 3 and Day 10 following Day 10 visits will be as per the treatment phase. - treatment phase - Screening, Day 1, Week 1, 2, 4, 8 and 12 (and Weeks 16, 20, and 24 for subjects requiring 24 weeks of treatment). AEs will be collected throughout the treatment phase;Main Objective: The primary objective of the PK Lead-in Phase of this study is: - To evaluate the steady state pharmacokinetics (PK) and confirm the dose of LDV/SOF FDC in chronic HCV-infected pediatric subjects The primary objective of the Treatment Phase of this study is: - To evaluate the safety and tolerability of LDV/SOF FDC for 12 or 24 weeks in chronic HCV-infected pediatric subjects;Secondary Objective: The secondary objective of the PK Lead-in Phase of this study: -Evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in chronic HCV-infected pediatric subjects The secondary objectives of the Treatment Phase of this study: - Determine the antiviral efficacy of 12 or 24 weeks of LDV/SOF FDC treatment in chronic HCV-infected subjects (including the impact of HCV genotype, IL28 genotype, and prior treatment experience) - Determine the antiviral efficacy of 12 oe 24 weeks of LDV/SOF FDC treatment in chronic HCV-infected subjects - Evaluate the kinetics of circulating HCV RNA during treatment and afte | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - For the PK Lead-in Phase, the secondary endpoint will include antiviral activity measurements including assessment of HCV RNA. AEs leading to permanent discontinuation of study drug will be evaluated as a secondary safety endpoint. - For the Treatment Phase, the key efficacy endpoint is SVR12 and secondary efficacy endpoints include SVR4, SVR24, breakthrough and relapse. Additional efficacy evaluations may include HCV RNA change from Day 1; ALT normalization; and viral kinetic parameters. Secondary safety endpoints of growth and development measurements will be assessed (e.g. height, weight, and Tanner Stage Assessment).;Timepoint(s) of evaluation of this end point: Efficacy endpoints at 4 and 24 weeks after treatment end PK and safety endpoints are accessed during the course of treatment | — |
Countries
Australia, New Zealand, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed