A study with Ledipasvir/Sofosbuvir for adolecents and children with chronic Hepatitis C infection.

• Conditions: Chronic Hepatitis C virus infection; MedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003578-17-Outside-EU/EEA
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-28
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

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.
2. 3 years to < 18 years of age as determined at Day 1 (consent of parent or legal guardian required)
3. PK Lead-in only: subjects in Cohort 1 (age 12 to <18 years of age) must weigh = 45 kg
4. PK Lead-in only: all subjects must be treatment naïve: no prior exposure to any IFN, RBV, or other approved or experimental HCV-specific DAA agent
5. Treatment experienced subjects: prior treatment failure to a regimen including interferon either with or without RBV that was completed at least 8 weeks prior to Day 1.
i. Interferon intolerant: Subject who discontinued therapy (= 12 weeks total) due to = 1 adverse event
ii. Interferon non-responder: Subject who did not achieve undetectable HCV RNA levels while on treatment
iii. Relapse/breakthrough: Subject who achieved undetectable HCV RNA during treatment or within 4 weeks of the end of treatment but did not achieve a sustained virologic response (SVR)
6. Chronic HCV-infection documented by either:
a) a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test
at least 6 months prior to the Day 1 visit, or
b) a liver biopsy performed prior to the Day 1 visit with evidence of chronic HCV-infection
7. Infection with HCV as determined at Screening.
8. HCV RNA = 1000 IU/mL at Screening
9. Adequate hematologic function (absolute neutrophil count = 1,500/mm3; hemoglobin = 11 g/dL or = 12 g/dL for GT-3 only ).
10. Negative serum beta-HCG pregnancy test
11. Subject able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator’s discretion
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
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. Pregnant or lactating subjects
2. Sexually-active males or females of childbearing potential who are not willing to use an effective method of contraception during the study
3. Decompensated liver disease
4. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency)
5. alpha-fetoprotein > 50 ng/mL
6. Serum creatinine > 1.5 mg/dL
7. Estimated glomerular filtration rate < 90 mL/min/1.73m2, as calculated by the Schwartz Formula
8. Evidence of hepatocellular carcinoma (HCC)
9. Co-infection with HIV, acute HAV, or HBV
10. Significant cardiovascular, pulmonary, or neurological disease
11. Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
12. History of solid organ or bone marrow transplantation
13. Chronic daily non-steroidal anti-inflammatory drug therapy
14. Systemic corticosteroid use for > 2 weeks (pulmonary/nasal administration is permitted)
15. Investigational agents taken within the past 28 days (except with the expressed approval of the Sponsor)
16. Clinically-relevant alcohol or drug abuse within 12 months of screening.
17. Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
18. Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
19. Use of any prohibited concomitant medications
20. PK Lead-in only: subjects with history of cirrhosis

Study & Design

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