A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection

Phase 1

• Conditions: Chronic Hepatitis C virus infection; MedDRA version: 17.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002283-32-IT
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-22
• Study Completion: 2018-09-13
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1) Positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Day 1 visit
2) Liver biopsy performed prior to the Day 1 visit with evidence of chronic HCV infection
3) Infection with HCV GT-2 or GT-3 as determined at Screening
4) HCV RNA = 1000 IU/mL at Screening
5) For the PK Lead-in Phase: subjects in cohort 1 (age 12 to <18 years of age) must weigh = 45kg
6) Agree to use 2 forms of highly effective contraception for the duration of the study and for 6 months (for female subjects) or 7 months (for male subjects) after the last dose of study medication.
7) Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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) Hematologic or biochemical parameters at screening outside the protocol-specified requirements
2) HIV, acute hepatitis A virus (HAV) or chronic HBV infection
3) History of or current decompensated liver disease
4) Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
5) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency)
6) Chronic use of systemic immunosuppressive agents or immunomodulatory agents
7) Active or recent history (= 1 year) of drug or alcohol abuse
8) History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified