KCT0000417招募中未知
A randomized, open labeled, multicenter study comparing entecavir versus lamivudine as antiviral prophylaxis for patients with hepatitis B infection undergoing cytotoxic chemotherapy for malignant tumors
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18 至 o Limit（—）
- 性别
- All
入选标准
- •1. HBsAg: positive for at least 6 months
- •2. Liver status: inactive or active carrier with ALT level < 2xUNL, chronic hepatitis & compensated cirrhosis (Child Pugh class A)
- •3. Disease and treatment: hematologic (confined to Non-Hodgkin lymphoma) and oncologic (confined to breast, stomach, colorectal, and lung cancer) malignant tumors undergoing adjuvant setting of systemic chemotherapy
- •4. Informed consent
排除标准
- •1. Coinfection status: anti-HCV or anti-HIV positive patients
- •2. Liver status: Decompensated liver cirrhosis (Child Pugh class B-C) or hepatocellular carcinoma
- •3. Underlying disease: Patients with an expected survival < 1 year
- •4. other hematologic malignancies except Non-Hodgkin lymphoma
- •5. other oncologic malignancies except breast, stomach, colorectal, and lung cancer
- •6. Patients who had already received antiviral therapy including LAM, ETV or antiviral therapy against HBV infection on the therapeutic purpose within 6 months prior to study entry.
- •7. Other causes of chronic liver disease except HBV, i.e. seropositive for anti-hepatitis C virus antibody, excessive alcohol consumption (>20 g/day), evidence of autoimmune hepatitis or hemochromatosis
- •8. Patients who had decompensated liver states such as jaundice, ascites, variceal bleeding, and hepatic encephalopathy as indicated by any one of the following:
- •- serum bilirubin > 3 mg/dL
- •- prothrombin time > 4 seconds prolonged or INR >1.7
- •- serum albumin < 3.0 g/dL
- •- History of ascites, variceal hemorrhage, or hepatic encephalopathy
- •- Child-Pugh score =7
- •9. Patients who have evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dL
- •10. Patients who received LAM or ETV as deferred treatment of hepatitis flare or acute exacerbation after initiation of chemotherapy
研究者
相似试验
进行中（未招募）
1 期
A randomized, open-label, multi-center study comparing a steroid sparing regimen versus standard steroid regimen in combination with daclizumab, mycophenolate mofetil and sirolimus in the prevention of acute renal allograft rejection.Estudio abierto, aleatorizado, multicéntrico, nacional, comparando un régimen libre de esteroides frente a un régimen de esteroides estándar, en combinación con Daclizumab, Micofenolato Mofetil y Sirolimus, en la prevención del rechazo agudo en trasplante renal.Renal TransplantEUCTR2005-003383-39-ESRoche Farma S.A.144
进行中（未招募）
1 期
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.EUCTR2006-000914-19-GBJanssen-Cilag International N.V.
进行中（未招募）
1 期
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.Anemia in cancer patients receiving chemotherapyMedDRA Version 5.1: list of preferred terma used in the process of defining thrombotic vascular events, see investigator's brochure epoetin alphaEUCTR2006-000914-19-FRJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
进行中（未招募）
不适用
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. - NDEUCTR2006-000914-19-ITJANSSEN-CILAG INTERNATIONAL NV500
进行中（未招募）
1 期
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.Anemia in cancer patients receiving chemotherapyMedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.EUCTR2006-000914-19-SKJohnson & Johnson Pharmaceutical Research & Development