EUCTR2007-002920-14-GB进行中（未招募）不适用
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infection
Tibotec BVBA0 个研究点目标入组 48 人开始时间: 2007年8月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •1. Male and female subjects, 18-65 years of age, inclusive.
- •2. Subjects chronically infected with either
- •a) genotype 2 HCV with HCV RNA > 10,000 IU/mL, or
- •b) genotype 3 HCV with HCV RNA >10,000 IU/mL.
- •Chronic disease status must be confirmed by at least one 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 HCV infection is met, or
- •- diagnosis of hepatitis C > 6 months before the screening period.
- •3. Subject has never received treatment for HCV (including investigational products).
- •4. Screening laboratory values of the following variables must meet the acceptable values defined below:
- •Absolute neutrophil count: = 1,500/mm3
- •Platelet count: = 100,000/mm3
- •Hemoglobin: Within normal range
- •All other hematology and biochemistry results must show no clinically significant abnormalities in the opinion of the investigator.
- •5. Subjects judged to be in good health, in the opinion of the investigator, on the basis of medical history and physical examination (including vital signs and screening ECG), with any chronic medical conditions under stable medical control.
- •6. If heterosexually active, female subjects of childbearing potential must agree to the use of two effective methods of contraception from screening until 4 months after last dose of RBV, as outlined in Section 5.2.4.
- •If heterosexually active, non-vasectomized male subjects who have a female partner of childbearing potential must agree to the use of two effective methods of contraception from screening until 7 months after last dose of RBV, as outlined in Section 5.2.4.
- •Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, in order to be eligible for this trial, female subjects must use 2 barrier methods during telaprevir/telaprevir placebo treatment and the subsequent month. Barrier contraceptives include but are not limited to the following methods: male condom, diaphragm with spermicidal gel, 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 condoms may cause the condoms to break). As of one month after completion of telaprevir/telaprevir placebo treatment, hormonal 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 sexual 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 2 years.
- •7. Subject is willing to refrain from the concomitant use of any medications or substances noted in Section 5.3.11.
- •8. Subject has signed ICF voluntarily before the first trial-related activity.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has 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. Subject has medical contraindications to the administration of an interferon (Peg-IFN alfa2a in particular) or RBV treatment, including but not limited to the following:
- •- abnormal thyroid stimulating hormone (TSH) levels or poorly controlled thyroid
- •- evidence of clinically significant cardiac dysfunction;
- •- history of psychiatric disorders determined by the investigator to contraindicate the use of IFN-based therapy;
- •- evidence of autoimmune disease;
- •- history of hemoglobinopathies.
- •3. Subject has history or evidence of decompensated liver disease as shown by screening laboratory results of any of the following:
- •a. international normalized ratio (INR) = 1.7;
- •b. serum albumin < 3.5 g/dL;
- •c. serum total bilirubin > 1.8 times the upper limit of normal (ULN), unless isolated and for subjects with Gilbert’s Syndrome;
- •d. history of ascitis, hepatic encephalopathy, bleeding esophageal varices.
- •4. Subject has 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 study procedures.
- •5. Subject has HIV or HBV co-infection.
- •6. Women who are pregnant, planning to become pregnant, or breastfeeding, and partners of women who are pregnant or breastfeeding.
- •7. Subject has hypersensitivity to tartrazine.
- •8. 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.
- •9. Subject has history or evidence of cirrhosis.
- •10. Subject has any evidence of significant liver disease in addition to hepatitis C infection, which may include, but is not limited to hepatitis B infection, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, Nonalcoholic Steatohepatitis (NASH), or primary biliary cirrhosis.
- •11. Subject is diagnosed with or has suspected hepatocellular carcinoma. Alfa-fetoprotein at screening must be < 50 ng/mL, or if higher, absence of a mass on an ultrasound or magnetic resonance imaging (MRI) needs to be documented within the screening period.
研究者
相似试验
进行中（未招募）
1 期
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 4 hepatitis C infectioHepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis CEUCTR2007-005281-12-FRTibotec BVBA
进行中（未招募）
不适用
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infectioHepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis CEUCTR2007-002920-14-SETibotec BVBA48
进行中（未招募）
1 期
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infectioEUCTR2007-002920-14-FRTibotec BVBA
进行中（未招募）
不适用
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infection - NDCHRONIC GENOTYPE 2 OR 3 HEPATITIS CMedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis CEUCTR2007-002920-14-ITTIBOTEC BVBA48
进行中（未招募）
1 期
A study on the safety, tolerability and immune response of meningococcal combined ABCWY vaccine in healthy infants.EUCTR2021-001367-24-FIGlaxoSmithKline Biologicals SA688