EUCTR2006-005500-14-DE进行中（未招募）不适用
A Randomized, Open-label, Multicenter, Efficacy and Safety Study Examining the Effects on Viral Kinetics of All-trans Retinoic Acid (Tretinoin) (VESANOID®)in Combination with PEG-IFN alfa 2a (PEGASYS®) and Ribavirin (COPEGUS®) Therapy in Patients with Genotype 1-Chronic Hepatitis C and Non-Response to a Previous Course of Peg-Interferon alfa-/Ribavirin Combination (ATRACTION) - ATRACTIO
niversitätsmedizin der Johannes-Gutenberg Universität Mainz0 个研究点开始时间: 2007年4月12日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Serological evidence of chronic Hepatitis-C infection by positive anti-HCV testing and detectable HCV-RNA in serum (>100 IE/ml)
- •Non-responder to the previous anti-HCV combination therapy with pegylated Interferon and Ribavirin. Non-response is defined as a lack of at least a > 2 log drop in HCV-RNA at any time point during the previous therapy of at least 12 weeks, or a > 2 log drop at week 12, but HCV-RNA still detectable at week 24. During the previous course Peginterferon and Ribavirin had to be administered in standard dose, that is e.g. at least 1.0 µg/kg/body weight/week Peginterferon alfa-2b and 800 mg/d Ribavirin at the beginning or at least 135 µg/week Peginterferon alfa-2a and 800 mg/d Ribavirin at the beginning.
- •Evidence of HCV Genotype 1 by means of reverse hybridisation assay Inno LiPA from Bayer Versant (Innogenetics) within 24 months before randomisation
- •Histological evidence of inflammation and fibrosis (> F1) in the liver with or without evidence of compensated cirrhosis within 24 months before randomisation (Child-Pugh grade A)
- •The previous anti-HCV therapy course had to be finished at least 6 months before randomisation into this study
- •Men and women aged 18 to 65 years
- •Negative urine- or serum-pregnancy test for women with childbearing potential within 24 hours before administration of the first dose of medication (also for fertile female partners of male patients)
- •For female patients: During administration of the study medication and during 6 months of treatment free follow-up two highly effective methods of contraception have to be used, one of them with a barrier function, that is condom; (Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, CPMP/ICH/286/95 mod); micro-dosed gestagenes („Minipille) and oral contraceptives with a content of < 20 µg Ethinylestradiol as a method of contraception are not sufficient when All-trans Retinoic acid is used!
- •For male patients and their female partners: During administration of the study medication and during 7 months of treatment free follow-up two highly effective methods of contraception have to be used, one of them with a barrier function, that is condom; (Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, CPMP/ICH/286/95 mod); micro-dosed gestagenes („Minipille) and oral contraceptives with a content of < 20 µg Ethinylestradiol as a method of contraception are not sufficient when All-trans Retinoic acid is used!
- •Written informed consent concerning the participation in the study
- •An ophtalmological examination is recommended for all patients before randomisation
- •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
- •Known hypersensitivity to the active substance of Peginterferon alfa-2a, to alfa-interferons or Ribavirin or one of the other ingredients
- •Known allergy to a substance of the class of retinoids or one of the other ingredients (e.g. allergy to soy beans or peanuts)
- •Persons under age or persons of age, that are not able to realize nature, meaning and significance of the clinical study and to adjust their will in that sense (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG)
- •Pregnancy or breastfeeding
- •Fertile women, not using highly effective methods of contraception
- •Male partners of pregnant women
- •Participation in another clinical study at the same time or within the last three months
- •Patients already included once into this study
- •Persons, that are eventually in dependence on the sponsor or investigator
- •Infection with HCV-Genotypes-2, -3, -4, -5 or -6
- •Evidence of HBsAg, HIV-antibodies during screening
- •Patients under immunosuppression
- •Treatment with systemic anti-neoplastic or immune modulatory medication (including supraphysiological oses of steroids or radiation) within the last 6 months before randomisation and throughout the whole study duration
- •Chronic hepatitis unrelated to Hepatitis-C-virus (e.g. Hemochromatosis, Autoimmunehepatitis, metabolic- or alcohol-related liver disease)
- •Decompensated cirrhosis or liver disease graded Child-Pugh grade B or C
- •Signs of a hepatocellular carcinoma before randomisation in case of a state of cirrhosis or transition to cirrhosis (_-Fetoprotein values > 100 ng/ml lead to exclusion of the patient from the study, with values of -Fetoproteins of > 50 ng/ml and < 100 ng/ml an HCC should be excluded by means of an established method)
- •Esophagael varices with bleeding in the medical history
- •Hemoglobin <12 g/dl for women and <13 g/dl for men during screening
- •Patients with an elevated risk for anemia (e.g. Thalassemia, Spherocytosis, etc.) or patients, for whom anemia would be a medical risk in particular
- •Neutropenia <1.500/ml or thrombocytopenia <70.000/ml during screening
- •Creatinine in serum >1,5 mg/dl during screening
- •Acute or known psychic illnesses or disturbances that negatively influence the ability of the patient to understand the requirements of this study
- •Severe depression in the medical history, defined as any sign on suicidal tendencies, or hospitalisation because of depression, or any exclusively antidepressive therapy of at least 3 months duration (an accompanying antidepressive treatment in the setting of a previous anti-HCV therapy with Interferons is allowed)
- •Severe psychotic or any other severe psychiatric disease in the medical history, defined as any antipsychotic or otherwise psychiatric treatment of at least 3 months duration in the medical history or any sign on suicidal tendencies or hospitalisation because of these illnesses
- •Patients with the state of excitation or irritation
- •Patients with delirant syndromes as well as exogenious psychosis in their medical history
- •Autoimmune diseases (e.g. chronic inflammatory bowel disease, idiopathic thrombocytopenic Purpura, Lupus erythematodes, Sklerodermia, severe Psoriasis, rheumatoid Arthritis)
- •Disturbances in thyroid function, impossible to adjust euthyreod by medication
- •Insufficiently adjusted Diabetes mellitus (HbA1c > 7%) or insufficiently adjusted hypertriglyceridemia (> 350 mg/dl)
- •Clinically manifest gout
- •Chronic pulmonary disease with functional restriction
- •Severe cardiac disease (e.g. cardiac insufficiency NYHA
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