NCT00381017撤回3 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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
研究概览
简要总结
This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously once weekly for 24-36 months) versus standard supportive care, using the time to any of the following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma [HCC]) as endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years but < 70 years, of either sex or any race.
- •Detectable plasma hepatitis C virus (HCV) RNA (all genotypes of HCV are permitted).
- •Cirrhosis of the liver within the last five years.
- •Compensated liver disease (Child-Pugh <8 with hepatic encephalopathy <=
- •No evidence of hepatocellular carcinoma (HCC) and a serum alpha fetoprotein (AFP) <100 ng/mL within two months of randomization/study enrollment.
- •Varices results via endoscopy within the last six months or at time of screening.
- •Serologic evidence of human immunodeficiency virus-
- •CD4 cell count >=100 /µL.
- •Platelet number of at least 50000 mm**
- •Neutrophil count of at least 750 mm**
- •Hemoglobin of >9.0 mg%.
- •Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
- •Hemoglobin A1c (HbA1c)<8.5%, to demonstrate controlled diabetes, if applicable.
- •Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
- •Creatinine clearance >50 mL/min, as assessed by the indirect calculation method.
- •Demonstrate stable status of HIV-1 infection.
- •On stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline, with the expectation of their HAART regimen (drugs and dosage) remaining unaltered for the first 8 weeks of the study OR
- •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). "Structured treatment interruptions" will be permitted during the study.
- •Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
- •Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.
排除标准
- •Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subject whose partner wants to become pregnant.
- •Using silymarin.
- •Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.
- •Any cause of liver disease other than chronic hepatitis C.
- •Suspected or having hypersensitivity to interferon.
- •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.
- •Present with a lesion suspicious for hepatic malignancy on the screening imaging.
- •Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).
- •Known coagulation or hemoglobin diseases.
- •Organ transplant, except corneal or hair transplant.
- •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 major depressive disorder.
- •Active HIV-related opportunistic infection and/or malignancy requiring systemic therapy.
- •Evidence of known severe retinopathy.
- •Subject has not observed the designated washout periods for any of the prohibited medications.
- •Participating in any other hepatitis C clinical study.
研究者
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