一个新的临床试验：聚乙二醇干扰素+替诺福韦 - 组合，然后

StephenW

    一个新的临床试验：聚乙二醇干扰素+替诺福韦 - 组合，然后单泰诺福韦
http://clinicaltrials.gov/ct2/show/NCT01369212?term=Hiv&rcv_s=05/25/201...
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (HBRN)
                         This study is not yet open for participant recruitment.   
                              Verified on July 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)   
            
      First Received on June 6, 2011.            Last Updated on July 20, 2011        History of Changes      
  

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	University of Pittsburgh
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT01369212

    Purpose  

This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be sustained HBsAg loss in serum one year after stopping all antiviral therapy (sustained off-treatment response).

      

Condition	Intervention
Hepatitis B	Drug: Tenofovir Drug: Combination of peginterferon alfa 2a and tenofovir

  
  

StephenW

联合治疗的聚乙二醇干扰素α- 2a和替诺福韦对替诺福韦单药治疗慢性乙型肝炎(HBRN）
这项研究是尚未公开招募参与者。
已核实2011年7月由国立糖尿病，消化道和肾脏疾病研究所（NIDDK）
            
2011年6月6日，第一次收到。最后更新于2011年7月20日，历史的变迁
  

主办单位：国家糖尿病，消化道和肾脏疾病研究所（NIDDK）

合作者：美国匹兹堡大学

提供的资料：国家糖尿病，消化道和肾脏疾病研究所（NIDDK）

ClinicalTrials.gov标识符：NCT01369212

目的

此项临床试验比较了24周为3.5年，仅4年成果的主要措施与慢性乙型肝炎患者替诺福韦的疗效与替诺福韦单药治疗的聚乙二醇干扰素加替诺福韦的疗效将持续HBsAg消失停止所有抗病毒治疗后血清一年（持续治疗反应的）。


      
条件       干预
B型肝炎  药物：泰诺福韦
             药物：聚乙二醇干扰素α2a和替诺福韦的组合

非东亚病夫

回复 StephenW 的帖子

是不是真的啊？？
好像联合治疗效果不错哦，

StephenW

非东亚病夫 发表于 2011-8-1 10:57
回复 StephenW 的帖子

是不是真的啊？？

我们尚不知道疗效结果，但它似乎医生要测试这些组合治疗。

候月

这种测试的入选条件，不知是哪些。
请教，到目前为止，有过哪一种、或哪一次测试，是针对肝功正常的携带者的么？

StephenW

候月 发表于 2011-8-1 14:34
这种测试的入选条件，不知是哪些。
请教，到目前为止，有过哪一种、或哪一次测试，是针对肝功正常的携带者 ...

据我所知，很少或根本没有是针对肝功正常的携带者. 这种测试的入选条: 24周期间内,两个血清ALT水平升高,间隔4周. Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

            Criteria
   

Inclusion criteria:

• Participant is enrolled in the HBRN Cohort Study and has completed the baseline evaluation, willing and able to provide informed consent
• 18 years or older
• Chronic hepatitis B infection
• Hepatitis B e antigen positive or negative
• Serum DNA ≥1000 IU/mL on 2 occasions ≥4 weeks apart within the prior 24 week period
• Two elevated serum ALT levels 4 weeks apart within the prior 24 week period
• Treatment Naive for the last 48 weeks
• Compensated liver disease
• No evidence of HCC
• Liver biopsy (done as standard of care) that shows findings consistent with chronic hepatitis B with histology activity index (HAI) ≥5 (necroinflammatory component only) or Ishak fibrosis score ≥2 or both. Slides must be available for review. If the participant had received previous treatment for hepatitis B, the biopsy must have been done after discontinuation of treatment.
  
  

Exclusion criteria:

• Serum ALT ≥450 IU/L for males and ≥300 IU/L for females
• History of hepatic decompensation including but not limited to ascites, variceal bleeding, or hepatic encephalopathy
• Liver biopsy with ≥3+/4 iron in hepatocytes by Prussian blue stain
• Known allergy or intolerance to any of the study medications
• Females who are pregnant or breastfeeding
• Females of childbearing potential unable or unwilling to use a reliable method of contraception during the treatment period
• Previous liver or other organ transplantation including engrafted bone marrow transplant
• Any other concomitant liver disease, including hepatitis C or D; Participants with severe steatohepatitis will be excluded (participants with non-alcoholic fatty liver disease [NAFLD] with steatosis only and/or mild to moderate steatohepatitis are acceptable)Presence of anti-HIV at screening-Renal insufficiency with calculated creatinine clearance <50 mL/min
• Platelet count <90,000 /mm3, hemoglobin <13 g/dl (males) or <12 g/dl (females), absolute neutrophil count <1500 /mm3 (<1000/mm3 for African-Americans) during the screening period
• History of active alcohol or drug abuse within 48 weeks of screening.
• Pre-existing psychiatric condition(s), including but not limited to: Current moderate or severe depression as determined by the study physician, history of depression requiring hospitalization within past 10 years, history of suicidal or homicidal attempt within the past 10 years, or history of severe psychiatric disorders including but not limited to schizophrenia, psychosis, bipolar disorder
• History of immune-mediated disease, or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, poorly controlled diabetes or uncontrolled seizure disorder
• Any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation
• Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study
• Evidence of active or suspected malignancy, or a history of malignancy within the last 144 weeks (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
• Need for ongoing use of any antivirals with activity against HBV during the course of the study
• Any other condition that in the opinion of the investigator would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
• Participation in any other clinical trial involving investigational drugs within 30 days of randomization or intention to participate in another clinical trial during this study.
  
  

非东亚病夫

临床前应该有小规模的实验啊~！
如果没有数据支持，那还搞什么临床啊？？