A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naïve subjects with chronic genytype 1 hepatitis C infection.

Tibotec BVBA0 个研究点目标入组 0 人开始时间: 2007年7月23日最近更新: 2021年10月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects who meet all of the following criteria are eligible for this trial.
•1. Male and female subjects 18-65 years of age, inclusive.
•2. Chronic genotype 1 hepatitis C infection. Chronic disease status must be confirmed by at least 1 of the following standard criteria:
•- history of a remote risk factor (e.g., intravenous drug abuse or blood transfusion), or
•- abnormal alanine aminotransferase (ALT) levels for > 6 months prior to screening
•(note: elevated ALT is not an inclusion criterion if one of the other criteria for chronic
•hepatitis C is met), or
•- diagnosis of hepatitis C > 6 months before the screening period.
•Note: To ensure an equal balance between the sub-genotypes 1a and 1b, the number of patients from either sub-genotype will be limited to a maximum of 60% of the total number of patients.
•3. Naïve of therapy for HCV (including investigational products).
•4. Screening laboratory values of the following variables must meet the acceptable values defined below:
•Laboratory variable Acceptable values
•Absolute neutrophil count = 1,500/mm³
•Platelet count = 100,000/mm³
•Bilirubin Within normal range (except for subjects with
•Gilbert’s Syndrome)
•Hemoglobin Within normal range
•All other hematology and clinical chemistry must show no clinically significant abnormalities, as judged by the investigator.
•5. Detectable plasma HCV RNA > 10,000 IU/mL at entry.
•6. Liver biopsy (preferred) or Fibroscan (alternative) within three years of the screening visit to assess the degree of liver fibrosis. If no biopsy or Fibrotest results are available at screening, such procedure should be performed as part of the screening procedures.
•7. Judged to be in otherwise good health, in the opinion of the investigator.
•8. Female subjects of childbearing potential must agree to the use of two effective methods of contraception, if heterosexually active, from screening until 4 months after last dose RBV. Non-vasectomized male subjects who have a female partner of childbearing potential must agree to the use of two effective methods of contraception, if heterosexually active, from screening until 7 months after last dose of RBV.
•Note: Oral contraceptives may not be reliable when taking telaprevir.Therefore, to be eligible for this trial, subjects should use 2 barrier methods during telaprevir treatment and the subsequent month. Barrier contraceptives include the following
•methods: male condom, diaphragm with spermicidal jelly, cervical cap, or female condom. (note that the female condom should not be used simultaneously with a latex male condom because the friction between the two condoms may cause the condoms to break)
•As of one month after completion of telaprevir treatment until 4 months (female subjects) or 7 months (male subjects and their female partners) after the last dose of RBV, oral contraceptives can be used as one of the 2 required efficient methods of birth control.
•Note: The use of birth control methods does not apply if the male partner has undergone a vasectomy or if the female sexual partner has had a bilateral oophorectomy, or a total hysterectomy, or if she is post-menopausal for at least two years.
•9. Willing to refrain from the concomitant use of any medications, substances or foods noted in Section 5.3.10.1.
•10. Informed Consent Form (ICF) signed voluntarily before first trial-related

排除标准

•Subjects meeting one or more of the following criteria cannot be selected.
•1. Presence of a concomitant medical condition that in the opinion of the investigator could influence the results of the trial or that could represent an additional risk for the administration of the study medication to the subject.
•2. Any medical contraindications to Peg-IFN alfa2a, Peg-IFN alfa2b, or RBV therapy
•including but not limited to the following:
•- abnormal thyroid stimulating hormone (TSH) levels (except if well-controlled on
•medication) or poorly controlled thyroid function;
•- evidence of clinically significant cardiac dysfunction;
•- history of psychiatric disorders determined by the investigator to contra-indicate the use of IFN-based therapy;
•- antinuclear antibody (ANA) titer = 1:320;
•- history of hemoglobinopathies.
•3. History or evidence of cirrhosis or decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices.
•4. 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.
•5. Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein at screening must be less than 50 ng/mL, or if higher, absence of a mass on an ultrasound or MRI must be documented within the screening period.
•6. History or suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with trial procedures.
•7. Human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection.
•8. Women who are pregnant, planning on becoming pregnant, or breast feeding, and partners of women who are pregnant or breast feeding.
•9. Hypersensitivity to tartrazine.
•10. Subject participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months.

研究者

发起方

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