Chronic Hepatitis C virus infection MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
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, in accordance with IRB/IEC/local requirements and the Investigator’s discretion. 2) 3 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prior use of an HCV NS5A inhibitor 2) Current or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) 3) Any of the following laboratory parameters at screening: a) INR > 1.2 x ULN b) Platelets 10 x the upper limit of normal (ULN) e) AST > 10 x ULN f) Direct bilirubin > 1.5 x ULN g) Estimated glomerular filtration rate < 90 mL/min/1.73m2, as calculated by the Schwartz Formula 4) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency) 5) Evidence of hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers) 6) Co-infection with HIV, acute HAV, or HBV (Hepatitis B Surface Ag positive at screening) 7) Current or prior history of any of the following: a) Significant cardiovascular, pulmonary, or neurological disease b) Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications c) History of solid organ or bone marrow transplantation d) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. 8) Clinically-relevant alcohol or drug abuse within 12 months of screening. 9) Sexually-active males or females of childbearing potential who are not willing to use an effective method of contraception during the study 10) Use of any prohibited concomitant medications 11) Investigational agents taken within the past 28 days (except with the express approval of the Sponsor) 12) Known hypersensitivity to the study drug, the metabolites, or formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PK Lead-in phase is: To evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) in pediatric subjects with chronic hepatitis C virus (HCV) infection Treatment Phase is: To evaluate the safety and tolerability of SOF/VEL for 12 weeks in paediatric subjects with chronic HCV;Secondary Objective: PK Lead-in Phase is: To evaluate the safety, tolerability, and antiviral activity of 7 days of dosing of SOF/VEL in paediatric subjects with chronic HCV Treatment Phase is: Determine the efficacy of SOF/VEL for 12 weeks in paediatric subjects with chronic HCV infection, as assessed by the proportion of subjects with SVR 12 weeks after cessation of treatment; Determine the proportion of subjects with SVR 4 and 24 weeks; Evaluate the proportion of subjects with virologic failure; Evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment; Evaluate the emergence of viral resistance to SOF and VEL during treatment and after cessation of treatment; Evaluate the effect of treatment with SOF/VEL on QoL; Evaluate the effect of SOF/VEL on growth and development of paediatric subjects during and after treatment; Evaluate the acceptability, including palatability, of formulations used;Primary end point(s): The primary endpoint of the PK Lead-in Phase is to determine steady-state PK, is AUCtau of VEL, SOF, and its major metabolite (GS-331007). The primary endpoint of the Treatment Phase is assessment of any AEs with a focus on AEs that lead to discontinuation of study drug.;Timepoint(s) of evaluation of this end point: PK lead in phase - Day 7 Treatment phase - SVR 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the PK Lead-in Phase are: - Antiviral activity measurements, including assessment of HCV RNA from baseline through Day 7. - Any AE leading to permanent discontinuation of study drug. The secondary endpoints of the Treatment Phase are: - The proportion of subjects with sustained virological response (SVR) 12 weeks after cessation of treatment (SVR12). SVR12 is the key efficacy endpoint. - The proportion of subjects with HCV RNA < LLOQ at 4 or 24 weeks after cessation of treatment (SVR4 and SVR24). - The proportion of subjects with virologic failure, including breakthrough/nonresponse and relapse - The proportion of subjects with HCV RNA < LLOQ on treatment - Emergence of viral resistance to SOF and /or VEL during treatment and treatment is discontinued - HCV RNA change from Baseline/Day 1 - Quality of life endpoints and neuropsychiatric assessments as measured by PedsQL™ Pediatric Quality of Life survey - Growth and development measurements including height and weight percentiles, Tanner Stage, parental height, and bone age - Acceptability assessed by swallowability and palatability ;Timepoint(s) of evaluation of this end point: SVR 4, 12 and 24 weeks | — |
Countries
Belgium, Italy, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed