A study with Ledipasvir/Sofosbuvir for adolecents and children with chronic Hepatitis C infection.
- Conditions
- Chronic Hepatitis C virus infectionMedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-003578-17-GB
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 226
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.
a) United Kingdom Only: The study will commence with GT-1, -3, and -4 HCV-infected pediatric subjects and will subsequently enroll subjects with GT-2, -5, and -6 once adult data is available, if appropriate.
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
1. Pregnant or lactating subjects
2. Sexually active subjects who are not willing to use 2 forms of an effective method of contraception, as referenced in Appendix 5
3. Treatment-naïve subjects with GT-3 HCV infection as determined at Screening. Treatment naïve is define by no prior exposure to any IFN, RBV, or other approved or experimental HCV-specific DAA agent
4. Decompensated liver disease
5. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency)
6. alpha-fetoprotein > 50 ng/mL
7. Serum creatinine > 1.5 mg/dL
8. Estimated glomerular filtration rate < 90 mL/min/1.73m2, as calculated by the Schwartz Formula
9. Evidence of hepatocellular carcinoma (HCC)
10. Co-infection with HIV, acute HAV, or HBV
11. Significant cardiovascular, pulmonary, or neurological disease
12. Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
13. History of solid organ or bone marrow transplantation
14. Chronic daily non-steroidal anti-inflammatory drug therapy
15. Systemic corticosteroid use for > 2 weeks (pulmonary/nasal administration is permitted)
16. Investigational agents taken within the past 28 days (except with the expressed approval of the Sponsor)
17. Clinically-relevant alcohol or drug abuse within 12 months of screening.
18. Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
19. 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
20. Use of any prohibited concomitant medications
21. PK Lead-in only: subjects with history of cirrhosis
22. 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 12 months prior to enrolled or has not required medication in the last 12 months may
be included
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