A trial investigating the safety and efficacy of a drug combination Sofosbuvir/Velpatasvir for Adolescents and Children with hepatitis C

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 216

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 < 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:
a) Treatment-naïve is defined as having never been exposed to an
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 or intolerance to a regimen containing interferon with or without RBV and
with or without a protease inhibitor that was completed at least 8 weeks prior to Day 1.
c) Interferon intolerant: Subject who discontinued therapy (= 12 weeks total) due to = 1 adverse event
6) A negative serum pregnancy test is required at screening and a negative urine test is required at Day 1 for female subjects of child
bearing 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 IMP 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: 1
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

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 < 50,000/mm3 c) albumin < 3.5 g/dL d) ALT > 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
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

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

Related Trials

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

Phase 1

Gilead Sciences, Inc.

Updated 5/4/2020