注册号: Registration number: |
ChiCTR-OOC-17013970 |
最近更新日期: Date of Last Refreshed on: |
2017-12-15 |
注册时间: Date of Registration: |
2017-12-15 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
注册题目: |
长期核苷类药物抗乙肝病毒治疗后停药的持久应答研究 |
Public title: |
Sustained Response After Discontinuation of Long-term Nucleos (t) ide Analogue Therapy in Chronic Hepatitis B Patients |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
长期核苷(酸)类药物治疗慢乙肝停药后持久应答的研究 |
Scientific title: |
Sustained Response After Discontinuation of Long-term Nucleos (t) ide Analogue Therapy in Chronic Hepatitis B Patients |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
彭劼 |
研究负责人: |
彭劼 |
Applicant: |
Jie Peng |
Study leader: |
Jie Peng |
申请注册联系人电话: Applicant telephone: |
+86 13802515784 |
研究负责人电话: Study leader's telephone: |
+86 13802515784 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
pjie138@163.com |
研究负责人电子邮件: Study leader's E-mail: |
pjie138@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
中国广东省广州市广州大道北1838号南方医科大学南方医院肝病中心 |
研究负责人通讯地址: |
中国广东省广州市广州大道北1838号南方医科大学南方医院肝病中心 |
Applicant address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
Study leader's address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
申请注册联系人邮政编码: Applicant postcode: |
510515 |
研究负责人邮政编码: Study leader's postcode: |
510515 |
申请人所在单位: |
南方医院 |
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Applicant's institution: |
NanFang hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
NFEC-201209-K3 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
南方医院医学伦理委员会 |
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Name of the ethic committee: |
Nanfang Hospital Medical Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2012-10-01 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
南方医院 |
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Primary sponsor: |
Nanfang hospital |
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研究实施负责(组长)单位地址: |
中国广东省广州市广州大道北1838号南方医科大学南方医院 |
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Primary sponsor's address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
南方医科大学 |
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Source(s) of funding: |
Southern Medical University,China |
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研究疾病: |
慢性乙型病毒性肝炎 |
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Target disease: |
chronic hepatitis B |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
比较长期核苷(酸)类药物治疗后,不同巩固治疗时间长度间的停药患者临床复发情况,以期探索最佳的巩固治疗时间。 |
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Objectives of Study: |
After long-term nucleoside (acid) treatment, the clinical recurrence of drug-withdrawal patients with different duration of consolidation treatment was compared in order to explore the best consolidation treatment time. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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纳入标准: |
1)18-60岁(含18岁和60岁),男性或女性。 2)进行任何与研究相关的步骤前,理解并签署知情同意书,并且遵守研究要求。 3)对于治疗前HBeAg阳性患者,持续口服核苷(酸)类药物治疗至HBV DNA在检测线以下、ALT复常、HBeAg发生血清转换后再继续巩固治疗至少24个月。 4)对于治疗前HBeAg阴性患者,治疗至HBV DNA在检测线以下、ALT复常后再继续巩固治疗至少36个月。 5)治疗前为代偿性肝病,无肝硬化证据。 6)筛选时WBC > 3.5G/L, PLT > 100G/L,AFP < 20ng/ml,ALT、AST正常,HBV DNA在检测线以下。 7)同意不参加任何其它研究。 |
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Inclusion criteria |
1. Aged 18 to 60 years old male or female; 2. Patients signed the informed consent form; 3. For HBeAg positive patients, therapy with nucleos(t)ide analogs should be received for at least 24 months with undetectable HBV DNA, normal ALT and HBeAg seroconversion; 4. For HBeAg negative patients, therapy with nucleos(t)ide analogs should be received for at least 36 months with undetectable HBV DNA and normal ALT; 5. Patients diagnosed as compensatory liver disease and with no evidence of liver cirrhosis before the therapy; 6. Patients with WBC > 3.5G/L, PLT > 100G/L, AFP < 20ng/ml, normal ALT and AST, and undetectable HBV DNA at base line; 7. Patient agreed not to participate in any other study. |
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排除标准: |
符合下列任一条件的受试者将不能入选本研究。 1)研究者判断认为患者依从性不佳或无法依从研究要求。 2)既往治疗前有失代偿肝病的临床症状,包括但不限于:TBIL≥2倍正常值上线(ULN),凝血酶原时间较ULN延长≥3秒,血清白蛋白低于32g/l,有肝功能失代偿病史(如腹水、静脉曲张破裂出血,或肝性脑病)。超声或放射检查发现可疑结节或AFP>20ng/mL。 3)停药前有肝活检的患者,提示有明显的桥样肝纤维化(>S3)。 4)停药前Fibroscan 提示有明显的肝纤维化或肝硬化。 5)合并有其它病毒感染,包括有HCV、HDV、HIV、自身免疫性肝病等。 6)合并其他任何严重的或活动性的疾病,包括任何未被控制的具有临床意义的肾脏、心脏、肺脏、血管性、神经性、消化性、代谢性疾病(如糖尿病、甲状腺疾病和肾上腺疾病)、免疫缺陷疾病或癌症。 7)接受过肝移植的患者或计划进行肝移植的患者。 |
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Exclusion criteria: |
Patientss who met any of the following criteria will not be eligible to this study; 1. The researchers consided that the patient could not comply with the study; 2. Patients with decompensated liver disease; 3. Patients with liver cirrhosis; 4. Patients with other viruses coninfection, such as HCV, HDV, HIV and autoimmune liver disease; 5. Patients with autoimmune diseases, cancer, other important organ dysfunctions and other serious complications; 6. Patients who had a liver transplant or plan to receive liver transplantation. |
研究实施时间: Study execute time: |
从From2012-12-01至To 2021-12-01 |
征募观察对象时间: Recruiting time: |
从From2012-12-01至To 2018-12-01 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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