EUCTR2012-004905-29-ES进行中（未招募）不适用
A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- 性别
- All
入选标准
- •-treatment-naïve (previously untreated) with confirmed chronic Hepatitis C Virus (HCV) infection
- •- liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
- •-liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)
- •- genotype 1 HCV infection (confirmed at screening)
- •- Before screening, a woman must be either not of childbearing potential: postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy OR of childbearing potential and practicing two different highly effective methods of birth control (including at least one barrier method) consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin 2 highly effective methods of birth control, as described above
- •- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use two different highly effective methods of birth control (including at least one barrier method). A man who is sexually active with a woman of childbearing potential and has had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. All men must also not donate sperm during the study and for 6 months (or longer if dictated by local regulations) after the last dose of RBV
- •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 146
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Participants who have been previously exposed to anti-HCV treatment, including any approved or investigational direct-acting antiviral (DAA) therapy
- •- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson?s disease, ?1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
- •- Participant is infected with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or human immunodeficiency virus (HIV-1 or HIV-2) (HIV-1 or HIV-2 antibody test positive at screening)
- •- Participant is infected with non-genotype 1 HCV
- •- Participant has advanced liver disease equivalent to Metavir status F3-F4 (bridging fibrosis or cirrhosis)
研究者
相似试验
进行中（未招募）
1 期
A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV InfectioHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-004905-29-BEJanssen-Cilag International NV230
进行中（未招募）
不适用
A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV InfectioHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 16.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-004905-29-ATJanssen-Cilag International NV225
进行中（未招募）
1 期
A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV InfectioHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 17.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2012-004905-29-GBJanssen-Cilag International NV230
进行中（未招募）
1 期
A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV InfectioEUCTR2012-004905-29-ITJanssen-Cilag International NV150
进行中（未招募）
不适用
A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV InfectioEUCTR2012-004905-29-DEJanssen-Cilag International NV225