A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children with Chronic HCV Infectio
- Conditions
- Chronic Hepatitis C virus infectionMedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-000480-87-PL
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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 < 18 years of age as determined at Day 1
3) Chronic HCV infection (= 6 months) as documented by prior medical history or liver biopsy
4) HCV RNA = 1000 IU/mL at Screening
5) Subjects must have a determination of prior treatment status as defined in protocol.
6) A negative serum pregnancy test is required at Screening and a negative urine test is required at Day 1 for female subjects of childbearing potential
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8) Lactating females must agree to discontinue nursing before the study drug is administered
9) Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 < 50,000/mm3
c) Albumin < 3.5 g/dL
d) ALT> 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method