An Open-Label, Single-Arm Phase III Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Subjects

Janssen R&D Ireland0 个研究点目标入组 100 人开始时间: 2011年11月21日最近更新: 2017年8月21日

试验速览

暂无简介。

•- Genotype 4 Hepatitis C virus (HCV) infection (confirmed at screening)
•- Plasma HCV ribonucleic acid (RNA) of > 10,000 IU/mL at screening
•- Participants should be either treatmentnaïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response
•- Participants must have voluntarily signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. To participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate ICF for this component (where local regulations permit). Refusal to give consent for this component does not exclude a participant from participation in the core study.
•- A liver biopsy is required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy.
•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 98
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•- Has an infection/co-infection with non-genotype 4 HCV
•- Has a co-infection with Human Immunodeficiency Virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
•- Has any of the following laboratory abnormalities: a. Platelet count < 90,000/mm3 (blacks: < 75 000 cells/mm3); b. Absolute neutrophil count (ANC) < 1500 cells/mm3 (Blacks: < 1000 cells/mm3); c. Hemoglobin < 12 g/dL for women and < 13 g/dL for men; d. Creatinine > 1.5 mg/dL; e. ALT and/or AST > 10 x upper limit of normal (ULN); f. Total serum bilirubin > 1.5 x ULN; g. Alpha-fetoprotein [AFP] > 50 ng/mL; h. Albumin serum concentration < 3.5 g/dL; i. Prothrombin time (PT) expressed as international normalized ratio (INR) > 1.5.
•- Uses disallowed concomitant therapy
•- Has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)

发起方

Janssen R&D Ireland