CTRI/2016/07/007105进行中（未招募）2 期
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-ArmStudy to Investigate the Safety and Efficacy ofSofosbuvir plus Ribavirin in Adolescents and Children withGenotype 2 or 3 Chronic HCV Infection. - Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria
- •-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.
- •-3 years to < 18 years of age (consent of parent or legal guardian required)
- •-PK Lead-in only: subjects in Cohort 1 (age 12 to <18 years of age) must weigh ï?³ 45 kg.
- •-PK Lead-in only: subjects in Cohort 2 (age 6 to <12 years of age) must weigh ï?³ 17 kg and < 45 kg
- •-PK Lead-in only: all subjects must be treatment naïve
- •-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.
- •-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
- •-Infection with HCV GT-2 or GT-3 as determined at Screening
- •-HCV RNA >= 1000 IU/mL at Screening
- •-Adequate hematologic function (absolute neutrophil count ï?³ 1,500/mm3; hemoglobin ï?³ 12 g/dL for males and ï?³ 11g/dL for females.)
- •-Negative serum ï?¢-HCG pregnancy test (for females of childbearing potential only, as defined in Appendix 5)
- •-Subject able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigatorâ??s discretion
- •Exclusion criteria
- •Pregnant or lactating subjects
- •-Sexually-active males or females of childbearing potential who are not willing to use an effective method of contraception during the study
- •-Decompensated liver disease defined as INR 1.2 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)
- •-Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilsonâ??s disease,
- •alpha-1 antitrypsin deficiency)
- •-Alfa fetoprotein 50 ng/mL
- •-Serum creatinine > 1.5 mg/dL
- •-Estimated glomerular filtration rate 90 mL/min/1.73m2, as calculated by the Schwartz
- •-Evidence of hepatocellular carcinoma (HCC) or other malignancy (with the exception of
- •certain resolved skin cancers)
- •-Co-infection with HIV, acute HAV, or HBV
- •-Significant cardiovascular, pulmonary or neurological disease
- •-Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of
- •orally administered medications
- •-History of solid organ or bone marrow transplantation
- •-Chronic daily non-steroidal anti-inflammatory drug therapy
- •-Systemic corticosteroid use for 5 days (pulmonary/nasal administration is permitted)
- •-Investigational agents taken within the past 28 days (except with the expressed approval of
- •the Sponsor)
- •-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
- •-Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- •-Any other condition (including alcohol or
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •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 (see Appendix 5 for further details)
- •3. Decompensated liver disease defined as INR ï?¾ 1.2 ï?´ ULN, platelets ï?¼ 50,000/mm3, serum albumin ï?¼ 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, Wilsonâ??s disease, alpha-1 antitrypsin deficiency)
- •5. ï?¡-fetoprotein ï?¾ 50 ng/mL
- •6. Serum creatinine > 1.5 mg/dL
- •7. Estimated glomerular filtration rate ï?¼ 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 ï?³ 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 enrollment or has not required medication in the last 12 months may be included
研究者
相似试验
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 InfectionChronic Hepatitis C virus infectionMedDRA version: 17.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-002283-32-ITGilead Sciences, Inc.106
进行中（未招募）
1 期
A study with sofosbuvir and ribavirin for adolecents and children with chronic Hepatitis C infection.EUCTR2014-002283-32-BEGilead Sciences, Inc.100
进行中（未招募）
1 期
A study with sofosbuvir and ribavirin for adolecents and children with chronic Hepatitis C infection.EUCTR2014-002283-32-DEGilead Sciences, Inc.100
进行中（未招募）
不适用
A study with sofosbuvir and ribavirin for adolecents and children with chronic Hepatitis C infection.Chronic Hepatitis C virus infectionMedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-002283-32-Outside-EU/EEAGilead Sciences, Inc.100
进行中（未招募）
1 期
A study with sofosbuvir and ribavirin for adolecents and children with chronic Hepatitis C infection.EUCTR2014-002283-32-GBGilead Sciences, Inc.106