NL-OMON39317已完成3 期
A Phase III, open-label trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec-sponsored Phase I study. - NAp
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject was previously randomized to the placebo group of a Phase II/III TMC435 study and did not achieve undetectable HCV RNA levels at the end of treatment or relapsed (confirmed detectable HCV RNA) within 1 year after end of treatment.;OR;Subject received short-term (up to 14 days) DAA treatment for HCV infection in a selected Tibotec-sponsored Phase I study on genotype 1;;- Subject must have completed the last study-related assessment in the previous study.;Please refer to the protocol for the complete list of inclusion criteria.
排除标准
- •- Subject shows evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy);;- Subject has co-infection with nongenotype 1 HCV. Since all subjects have previously participated in a study evaluating subjects with genotype 1 HCV infection, this screening test is at the discretion of the investigator, to rule out nongenotype 1 HCV infection in case of clinical signs of acute hepatitis infection and suspicion of possible re-infection;;- Subject has co-infection with HIV type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at Screening);;- Subject has any of the following laboratory abnormalities at screening: platelet count * 90,000/mm3; absolute neutrophil count < 1500 cells/mm3 (blacks: < 1200 cells/mm3; hemoglobin < 12 g/dL for women and < 13 g/dL for men; creatinine >1.5 mg/dL; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 10 x ULN; total serum bilirubin > 1.5 x ULN. Note: Retesting of an abnormal laboratory or urinalysis result that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility;;- Subject received any DAA HCV therapy, other than having received short-term (up to 14 days) DAA in a selected Tibotec-sponsored Phase I study;;- Subject prematurely stopped medication in the previous TMC435 study for noncompliance;;- Subject prematurely stopped medication in the previous TMC435 study for safety reasons, and it would therefore be unsafe to repeat treatment at investigator*s discretion.;Please refer to the protocol for the complete list of exclusion criteria
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