EUCTR2013-002726-23-ES
进行中（未招募）
不适用
Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation
Janssen R&D, Ireland0 个研究点目标入组 40 人2013年10月1日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hepatitis C Virus (HCV) genotype-1b Infection
- 发起方
- Janssen R&D, Ireland
- 入组人数
- 40
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Liver transplant between 6 months and 10 years prior to the screening visit
- •\-Hepatitis C virus (HCV) genotype 1 subtype b infection
- •\- Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
- •\- HCV treatment\-naïve participants must not have received post\-OLT treatment with any approved or investigational drug for the treatment of HCV
- •\- Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 38
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •\- Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
- •\- Any liver disease of non\-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
- •\- Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
- •\- Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV\-1 or HIV\-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
- •\- Multi\-organ transplant that included heart, lung, pancreas, or kidney
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver TransplantatioHepatitis C Virus (HCV) genotype-1b InfectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2013-002726-23-ITJanssen R&D, Ireland40
进行中（未招募）
1 期
未命名试验EUCTR2015-001693-18-ITCELGENE CORPORATIO18
已完成
2 期
A Phase 2a Open Label Study to Evaluate the Pharmacokinetics and Safety of Parathyroid Hormone hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in Healthy Postmenopausal WomeOsteoporosisMusculoskeletal - OsteoporosisMetabolic and Endocrine - Other metabolic disordersACTRN12615000195550Corium International, Inc39
进行中（未招募）
不适用
A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatmentexperienced HIV-1 infected children and adolescents. - NDEUCTR2005-006179-11-ITTIBOTEC PHARMACEUTICALS LTD.80
进行中（未招募）
不适用
A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatment-experienced HIV-1 infected children and adolescents.Estudio en Fase II, abierto, para investigar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de TMC114/rtv (Ritonavir) dos veces al día en niños y adolescentes infectados por VIH-1 previamente tratadosEUCTR2005-006179-11-ESTibotec Pharmaceuticals Ltd.80