EUCTR2005-003876-39-BE进行中（未招募）1 期
A Randomized, Open-label, Multi-center, Phase 3, 2-arm Study Evaluating the Efficacy and Safety of Peg interferon Alfa-2b Low-dose Maintenance Monotherapy Versus Standard Supportive Care in Patients With Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus – The ENDURE Study. - ENDURE
Integrated Therapeutics Group, Incorporated-a subsidiary of Schering Plough0 个研究点目标入组 448 人开始时间: 2006年8月30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
- 448
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
- •To be eligible for enrollment, subjects must meet the following inclusion criteria:
- •1) Display the willingness and ability to participate in the study by demonstrating full comprehension of and agreement to comply with all study procedures by signing the written informed consent.
- •2) =18 years but < 70 years, of either sex or any race.
- •3) Detectable plasma HCV RNA with all genotypes of HCV permitted. Historical PCR and genotype are acceptable for study entry and will be confirmed at screening through the central lab.
- •4) Previous non-responders or intolerant to any pegylated alpha interferon plus ribavirin (cannot be on therapy for 2 weeks prior to randomization) or subjects unwilling to complete a full course of any combination treatment (pegylated alpha interferon plus ribavirin) are eligible for this study.
- •5) Cirrhosis of the liver, confirmed by histopathologic findings.
- •6) Compensated liver disease measured by the Child-Pugh clinical classification with the hepatic encephalopathy measure equal to one and the total score less than or equal to 8.
- •7) No evidence of HCC on abdominal ultrasound, CT scan, or MRI scan, and a serum AFP <100 ng/mL within 90 days of randomization/study .
- •8) Endoscopy to determine if evidence of bleeding (prior or present) due to esophageal varices, gastric varices, or portal gastropathy within six months of randomization/study enrollment. (If evidence of prior variceal bleeding, the patient is not eligible for the study).
- •9) Serologic evidence of HIV infection by HIV antibody or detection of HIV RNA. (Historical HIV RNA is acceptable for study entry and will be confirmed at screening through a central lab).
- •10) CD4 cell count =100 /µL, regardless of HIV RNA load.
- •11) Platelet number of at least 50000 mm3.
- •12) Neutrophil count of at least 750 mm3.
- •13) Hemoglobin of >9.0 g/dL.
- •14) Any serum ALT/AST liver enzyme level.
- •15) Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
- •16) HbA1c<8.5%, to demonstrate controlled diabetes, if applicable.
- •17) Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
- •18) Creatinine clearance >50 mL/min, as assessed by the indirect calculation method (Appendix 5).
- •19) Demonstrate stable status of HIV infection, in the opinion of the principal investigator, (e.g., subjects who are expected to progress in the first 3 months of the study would not be appropriate for enrollment).
- •20) On stable antiretroviral therapy (HAART) for at least 8 weeks prior to baseline.
- •21) Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization).
- •22) Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
- •23) While abstinence from sexual activity is the only certain method to prevent pregnancy, female subjects of childbearing potential (includes women who are less than two years post-menopausal and wom
排除标准
- •Any subject will be excluded from entry into the study if they have ANY of the following criteria:
- •1) Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subjects whose partner wants to become pregnant.
- •2) Using silymarin.
- •3) Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.
- •4) 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
- •5) Suspected or having hypersensitivity to interferon.
- •6) History of liver decompensation status or other evidence of bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy, jaundice or other conditions consistent with decompensated liver disease.
- •7) Present with a lesion suspicious for hepatic malignancy (HCC or metastasis/metastases) on the screening imaging.
- •8) Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).
- •9) Known coagulation (e.g., hemophilia) or hemoglobin (e.g., thalassemia) diseases that in the opinion of the investigator presents a risk to the patient to participate in the study
- •10) Organ transplant, except corneal or hair transplant.
- •11) Any known preexisting medical condition that, in the investigator’s opinion, could interfere with the subject's participation in and completion of the 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:
- •i) Hospitalization for depression
- •ii) Electroconvulsive therapy for depression, or
- •iii) 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 (either on or off drugs), 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 six 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, sc
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