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
Interventions
Trade Name: Vosevi 400 mg/100 mg/100 mg film-coated tablets
Product Name: Vosevi
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SOFOSBUVIR
CAS Number: 1190307-88-0
Current Sponsor code:
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject or parent/ legal guardian able to provide written informed consent prior to any screening evaluations. Willing to comply with study requirements in accordance with IEC/local requirements and the Investigator’s discretion. Subject will provide assent, if possible. 2) 3 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Current or prior history of clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage) 2) Any of the following laboratory parameters at Screening: a) INR >1.2 x ULN b) Platelets 10 x 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 3) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency) 4) Evidence of hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) 5) Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive at Screening) 6) Current or prior history of any of the following: a) Clinically significant illness (other than HCV) or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded b) Significant cardiac disease c) Gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications d) History of solid organ or bone marrow transplantation e) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well controlled on a stable treatment regimen for at least 6 months prior to enrollment or has not required medication in the last 12 months may be included 7) Clinically relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator 8) Use of any prohibited concomitant medications 9) Investigational agents taken within the past 28 days (except with the approval of the sponsor) 10) Known hypersensitivity to the study drug, the metabolites, or formulation excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the steady-state pharmacokinetics (PK) and confirm age-appropriate dose of SOF/VEL/VOX FDC in pediatric subjects with chronic HCV infection ;Secondary Objective: To evaluate the safety and tolerability of SOF/VEL/VOX FDC in pediatric subjects with chronic HCV infection To evaluate the antiviral efficacy of SOF/VEL/VOX FDC treatment in pediatric subjects with chronic HCV infection, as assessed by the proportion of pediatric subjects with sustained virological response (SVR) 12 weeks after cessation of treatment (SVR12) To evaluate the antiviral efficacy SOF/VEL/VOX FDC treatment in pediatric subjects with chronic HCV infection, as assessed by the proportion of pediatric subjects with SVR 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) To evaluate the proportion of pediatric subjects with virologic failure, including on-treatment virologic failure and relapse To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment Please refer to protocol for full list of secondary objectives of the trial. ;Primary end point(s): The appropriateness of the SOF/VEL/VOX FDC dose will be assessed by evaluating its steadystate PK. The primary PK endpoint is AUCtau of SOF, its major metabolite (GS-331007), VEL and VOX.;Timepoint(s) of evaluation of this end point: 12 weeks post last treatment dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: 1) Any AE leading to permanent discontinuation of study drug 2) The proportion of subjects with sustained virological response (SVR) 12 weeks after cessation of treatment (SVR12) is the key efficacy endpoint 3) The proportion of subjects with HCV RNA < LLOQ at 4 or 24 weeks after cessation of treatment (SVR4 and SVR24) 4) The proportion of subjects with virologic failure, including on-treatment virologic failure and relapse 5) The proportion of subjects with HCV RNA < LLOQ on treatment 6) Emergence of viral resistance to SOF, VEL, and VOX during treatment and treatment is discontinued 7) HCV RNA change from Day 1 8) Growth and development measurements including height and weight percentiles, Tanner Stage, radiographic bone age and two bone turn-over biochemical markers (CTX and P1NP) 9) Acceptability, including palatability, and swallowability assessments 10) Neuropsychiatric assessments as measured by PedsQL™ Pediatric Quality of Life survey;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment or at 12 and 24 weeks following discontinuation of treatment | — |
Countries
Germany, Italy, Poland, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed