新新药通
返回搜索
正在招募IV 期编号 NCT06306300

Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil)

报名条件（概要）

  • 年龄：18 Years – 79 Years
  • 性别：不限
  • 健康志愿者：接受

完整入排标准请以官方页面为准。

开展国家/地区

Brazil

药品与企业信息

Specialist - Epclusa 400Mg-100Mg Tablet药物

其他名称：Standard-of-Care (SC) HCV treatment

HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by a specialized doctor.

Non- specialist - Epclusa 400Mg-100Mg Tablet药物

其他名称：Simplified-and-Decentralized (SD) HCV treatment

HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by non-specialized doctor.

HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)诊断检测

HCV Self-Testing kit (oral fluid or blood-based) for HCV testing

HCV Rapid Testing kit诊断检测

Standard-of-care: HCV Rapid Test

研发企业

Oswaldo Cruz Foundation研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Conselho Nacional de Desenvolvimento Científico e TecnológicoOTHER_GOV

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study). The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS.

适应症

Hepatitis C

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人（申办方／研究总部）

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

管理档案

档案只保存在您自己的浏览器里，不会上传，任何人（包括本站）都看不到。

英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil)
ClinicalTrials.gov Identifier: NCT06306300
Sponsor: Oswaldo Cruz Foundation
Investigational product: Specialist - Epclusa 400Mg-100Mg Tablet, Non- specialist - Epclusa 400Mg-100Mg Tablet, HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST), HCV Rapid Testing kit

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil)
试验编号：NCT06306300
申办方：Oswaldo Cruz Foundation
研究药物：Specialist - Epclusa 400Mg-100Mg Tablet、Non- specialist - Epclusa 400Mg-100Mg Tablet、HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)、HCV Rapid Testing kit

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 hugo.perazzo@ini.fiocruz.br

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面