EUCTR2014-002283-32-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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 (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 greater than or equal to 45 kg
- •4. PK Lead-in only: subjects in Cohort 2 (age 6 to <12 years of age) must weigh greater than or equal to 17 kg and < 45 kg
- •5. PK Lead-in only: all subjects must be treatment naïve
- •6. 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 Baseline/Day 1.
- •7. 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
- •8. Infection with HCV GT-2 or GT-3 as determined at Screening
- •9. HCV RNA = 1000 IU/mL at Screening
- •10. Adequate hematologic function (absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 12 g/dL for males and greater than or equal to 11g/dL for females.)
- •11. Negative serum beta-HCG pregnancy test (for females of childbearing potential only, as defined in Appendix 5)
- •12. 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: 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
排除标准
- •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 defined as INR > 1.2 x ULN, platelets < 50,000/mm3, serum albumin > 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage)
- •4. Chronic liver disease of a non-HCV etiology (e.g., 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) or other malignancy (with the exception of certain resolved skin cancers)
- •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 > 5 days (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. 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
- •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 as described in Section 5.6 within 28 days of the Day 1 visit
- •20. 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.
研究者
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