Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
2020年2月18日 更新者：Gilead Sciences
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
研究概览
研究类型
介入性
注册 (实际的)
111
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Changhua、台湾
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Chiayi City、台湾
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Kaohsiung、台湾
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Kaohsiung City、台湾
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Keelung、台湾
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Taichung、台湾
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Tainan、台湾
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Tainan City、台湾
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Taipei、台湾
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Taipei City、台湾
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Taoyuan、台湾
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
- Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
- Cirrhosis determination by Fibroscan
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female or male is of childbearing potential
Key Exclusion Criteria:
- Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or nursing female
- Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
- Hepatocellular carcinoma (HCC) or other malignancy
- Current or prior history of clinical hepatic decompensation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LDV/SOF
LDV/SOF FDC for 12 weeks
|
90/400 mg FDC 片剂，每天口服一次
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
大体时间：Posttreatment Week 12
|
SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
|
Posttreatment Week 12
|
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Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
大体时间：First dose date up to 12 weeks
|
First dose date up to 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
大体时间：Posttreatment Week 4
|
SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.
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Posttreatment Week 4
|
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
大体时间：Weeks 1, 2, 4, 8, and 12
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LLOQ = 15 IU/mL
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Weeks 1, 2, 4, 8, and 12
|
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Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
大体时间：Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
|
LLOQ = 15 IU/mL
|
Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
|
|
HCV RNA Change From Baseline While on Treatment
大体时间：Weeks 1, 2, 4, 8, and 12
|
Weeks 1, 2, 4, 8, and 12
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|
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Percentage of Participants With Virologic Failure
大体时间：First dose date up to Posttreatment Week 12
|
Virologic failure was defined as :
|
First dose date up to Posttreatment Week 12
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Plasma HBV DNA Change From Baseline While on Treatment
大体时间：Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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|
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Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
大体时间：Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
|
Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
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|
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HBsAg Level Change From Baseline While on Treatment
大体时间：Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
|
|
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HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
大体时间：Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
|
Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
|
|
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Serum LOXL-2 Level Change From Baseline While on Treatment
大体时间：Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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|
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Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
大体时间：Posttreatment Weeks 4, 12, and 36
|
Posttreatment Weeks 4, 12, and 36
|
|
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Percentage of Participants That Required HBV Therapy During the Study
大体时间：First dose date up to Posttreatment Week 108
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First dose date up to Posttreatment Week 108
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Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
大体时间：Posttreatment Weeks 12, 60, and 108
|
FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:
|
Posttreatment Weeks 12, 60, and 108
|
|
Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
大体时间：First dose date up to Posttreatment Week 108
|
First dose date up to Posttreatment Week 108
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients With Chronic Hepatitis C and Hepatitis B Coinfection: a Phase 3 Study in Taiwan [Poster SAT-243]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Declines in HBsAg Levels Observed During Treatment With Ledispavir/Sofosbuvir in Patients With Chronic Hepatitis B Virus and Hepatitis C Virus Infection [Poster 1083]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, Chang TT, Massetto B, Yang JC, Yun C, Knox SJ, Osinusi A, Camus G, Jiang D, Brainard DM, McHutchison JG, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology. 2018 Mar;154(4):989-997. doi: 10.1053/j.gastro.2017.11.011. Epub 2017 Nov 22.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan [Presentation]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.
- Liu CJ, Sheen IS, Chen CY, Chuang WL, Wang HY, Tseng KC, Chang TT, Yang J, Massetto B, Suri V, Camus G, Jiang D, Zhang F, Gaggar A, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年12月22日
初级完成 (实际的)
2017年1月4日
研究完成 (实际的)
2018年11月7日
研究注册日期
首次提交
2015年11月23日
首先提交符合 QC 标准的
2015年11月23日
首次发布 (估计)
2015年11月25日
研究记录更新
最后更新发布 (实际的)
2020年3月6日
上次提交的符合 QC 标准的更新
2020年2月18日
最后验证
2019年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GS-US-337-1655
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Qualified external researchers may request IPD for this study after study completion.
For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
IPD 共享时间框架
18 months after study completion
IPD 共享访问标准
A secured external environment with username, password, and RSA code.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.