EUCTR2004-000488-83-ES进行中（未招募）1 期
A Study to Assess Treatment with PEG-Intron® and Rebetol® in Naïve Patients with Genotype 1 Chronic Hepatitis C and Slow Virological Response - Slow responder study
Intergrated Therapeutics Group, Incorporated-a subsidiary of Schering Plough0 个研究点目标入组 1,200 人开始时间: 2006年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
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
入选标准
- •All previously untreated (naïve), genotype-1 chronic hepatitis C patients are eligible for enrollment in this protocol.
- •1.Adult subjects aged 18 to 70 years, of either sex.
- •2.Genotype-1 HCV-RNA-positive patients.
- •3.Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits):
- •a)Hemoglobin values of >12 gm/dL for females and 13 gm/dL for males.
- •b)WBC >3,000/mm3
- •c)Neutrophil count >1,500/mm3
- •d)Platelet count >80,000/mm3
- •e)Direct bilirubin WNL
- •f)Indirect bilirubin WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be <3.0 mg/dL (<51.3 µmol/L)
- •g)Albumin WNL
- •h)Serum creatinine WNL
- •i)ALT level above ULN at screening
- •4.At the Screen Visit, fasting glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be <140 mg/dL and HbA1C <8.5%. HbA1C must be <8.5% in diabetic subjects (whether on medication or diet controlled). ANA must be ? 1:320
- •5.Thyroid Stimulating Hormone (TSH) WNL whether in euthyroid subjects or subjects requiring medical treatment. (subjects requiring medication to maintain TSH levels within normal limits are eligible if all other inclusion/exclusion criteria are met)
- •6.Double-barrier contraception for female subjects until 6 months post-treatment, for male subjects until 7 months post-treatment.
- •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
- •1.Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with some interferon or ribavirin product, whether alone or in combination.
- •2.Subjects weighing over 125 kg.
- •3.Suspected hypersensitivity to any interferon or ribavirin product.
- •4.Coinfection with HBV, HIV, or both.
- •5.HCV genotype 2, 3, 4, or other non-1 genotype
- •6.Any cause of liver disease other than chronic hepatitis C, including but not limited to:
- •a)Hemochromatosis
- •b)Alpha-1 antitrypsin deficiency
- •c)Wilson's disease
- •d)Autoimmune hepatitis
- •e)Alcoholic liver disease
- •f)Non-alcoholic steatohepatitis (NASH)
- •g)Drug-related liver disease
- •7.Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
- •8.Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia)
- •9.Known G6PD deficiency
- •10.Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
- •11.Subjects with organ transplants, except for corneal or hair transplant.
- •12.Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
- •a)Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
- •?hospitalization for depression
- •?electroconvulsive therapy for depression, or
- •?depression causing a prolonged absence from work or significantly altering daily functions.
- •Patients with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the patient; this management plan will become a part of the patient's medical record.
- •b)Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication.
- •c)Clinically significant ECG abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).
- •d)Chronic lung disease (e.g., chronic obstructive lung disease)
- •e)Poorly controlled diabetes mellitus
- •f)Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
- •g)Clinical gout
- •13.Subject is or was a substance abuser, such as alcohol (= 80 gm/day), methadone, IV, oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included
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