EUCTR2006-004665-33-DE进行中（未招募）不适用
A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects with Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response with a Prior Course of Interferon Based Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •- Male and female subjects, 18 to 70 years of age, inclusive.
- •- Genotype 1 (confirmed by standard testing), chronic hepatitis C. Chronic (non-acute) disease status must be confirmed by detectable plasma HCV RNA.
- •- Liver biopsy within 3 years of the date of the Screening Visit. - Judged to be in good health on the basis of medical history and physical examination (including vital signs and ECG), with any chronic medical conditions under stable medical control.
- •- Both Screening Visit 1 and Screening Visit 2 laboratory values must be within protocol specified laboratory reference ranges.
- •- Did not achieve SVR with at least 1 adequate prior course of Peg-IFN in combination with RBV (Peg-IFN/RBV) as defined by the protocol. Subjects must have received the last dose of Peg-IFN or RBV at least 12 weeks before the screening visit for this study.
- •- Must agree to use 2 methods of contraception that are highly effective, including one barrier method, during and for 24 weeks after the last dose of study drug (unless the subject is a woman of documented non-child-bearing potential). Female partners of male subjects must use the same precautions.
- •- Female subjects of child-bearing potential must have a negative pregnancy test at all visits (screening and predose Day 1) before the first dose of study drugs.
- •- Willing to refrain from the concomitant use of any medications, substances, or foods noted in Section 21.
- •- Able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions.
- •- Agree not to participate in other clinical studies for the duration of his/her participation in this trial through antiviral follow-up.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any medical contraindications to Peg-IFN or RBV therapy.
- •- Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject’s medical history.
- •- Participation in any clinical trial of a HCV protease inhibitor of any duration.
- •- Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
- •- History of or current evidence of decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices.
- •- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis.
- •- Diagnosed or suspected hepatocellular carcinoma.
- •- Alcohol or drug abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
- •- Women who are pregnant or breast-feeding. - Male partners of women who are pregnant or breast-feeding.
- •- Hypersensitivity to tartrazine (yellow dye #5).
研究者
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