EUCTR2004-000488-83-GB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
Schering Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 1,200 人开始时间: 2005年4月22日最近更新:
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 subjects are eligible for enrollment in this protocol.
- •1. Adult subjects aged 18 to 70 years, of either sex.
- •2. Genotype-1 HCV-RNA-positive subjects.
- •3. Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.
- •4. Confirmation of liver biopsy availability: Availability of a liver biopsy performed within 18 months prior to the Screen visit, with a pathology report confirming the histological diagnosis of chronic hepatitis or liver cirrhosis.
- •5. Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits, ULN = Upper Limit Normal):
- •a) Hemoglobin values of equal or more than 12 gm/dL for females and 13 gm/dL for males.
- •b) WBC equal to or more than 3,000/mm3
- •c) Neutrophil count equal to or more than 1,500/mm3
- •d) Platelet count equal to or more than 80,000/mm3
- •e) Direct bilirubin up to 10% above ULN is acceptable
- •f) Indirect bilirubin up to 10% above ULN is acceptable (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be less than or equal to 3.0 mg/dL (less than or equal to 51.3 µmol/L)
- •g) Albumin up to 10% above ULN is acceptable
- •h) Serum creatinine up to 10% above ULN is acceptable
- •i) ALT level above ULN at Screen
- •6. At the Screen Visit, glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).
- •Fasting specimens are not required, only preferred to reduce repeat lab testing. Results within protocol specifications from non-fasting specimens are acceptable
- •7. ANA must be less than or equal to 1:320
- •8. 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)
- •9. Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.
- •10. Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods :
- •1) contraceptive pill or IUD or depot hormonal preparation (ring, injection implant) and
- •2) a barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician.
- •Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of
排除标准
- •1. Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.
- •2. Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with some interferon or ribavirin product, whether alone or in combination.
- •3. Subjects weighing over 125 kg.
- •4. Suspected hypersensitivity to any interferon or ribavirin product.
- •5. Participation in other clinical trial within 30 days prior to screen into this study.
- •6. Coinfection with HBV, HIV, or both.
- •7. 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
- •8. Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
- •9. Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia)
- •10. Known G6PD deficiency
- •11. Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
- •12. Subjects with organ transplants, except for corneal or hair transplant.
- •13. 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.
- •Subjects 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 subject; this management plan will become a part of the subject'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
- •14. Subject is or was a substance abuser, such as alcohol (80 gm/day or more), methadone, IV, oral or inhaled drugs. To be considered for inclusion into the protocol, t
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