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正在招募III 期编号 NCT07209761

A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis

报名条件（概要）

  • 年龄：14 Years – 不限
  • 性别：不限
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

China、Georgia、India、Indonesia、Japan、Moldova、Peru、Philippines、South Africa、South Korea

药品与企业信息

Bedaquiline药物

其他名称：BDQ; B

In the BPaQM and BPaQ experimental arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 100 mg once daily for 15 weeks in the BPaQM arm or 24 weeks in the BPaQ arm. In the BPaLM and BPaL control arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 24 weeks.

Quabodepistat药物

其他名称：OPC-167832; QBS; Q

Quabodepistat 30 mg administered orally once daily under fed conditions, during or immediately after a meal. Quabodepistat is administered for 4 months, with a target of 120 treatment days, in the BPaQM arm and for 6 months, with a target of 180 treatment days, in the BPaQ arm.

Pretomanid药物

其他名称：PMD; Pa

Pretomanid 200 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM, BPaQ, and BPaL arms.

Moxifloxacin药物

其他名称：MFX; M

Moxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm.

Linezolid药物

其他名称：LZD; L

Linezolid 600 mg administered orally once daily for 6 months in the BPaLM and BPaL arms. Protocol-defined dose reduction to 300 mg once daily, temporary interruption, or discontinuation may be permitted to manage significant toxicity after consultation with the medical monitor.

研发企业

Otsuka Pharmaceutical Development & Commercialization, Inc.企业

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

Pretomanid

Viatris Specialty LLC

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）

This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or multidrug-resistant pulmonary tuberculosis. Participants are assigned to 1 of 2 cohorts based on fluoroquinolone susceptibility. In the fluoroquinolone-susceptible cohort, participants are randomized 1:1 to receive either a 4-month experimental regimen of bedaquiline, pretomanid, quabodepistat, and moxifloxacin or a 6-month control regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. In the fluoroquinolone-resistant cohort, participants are randomized 3:1 to receive either a 6-month experimental regimen of bedaquiline, pretomanid, and quabodepistat or a 6-month control regimen of bedaquiline, pretomanid, and linezolid. A total of approximately 532 participants are planned, including 432 participants in the fluoroquinolone-susceptible cohort and approximately 100 participants in the fluoroquinolone-resistant cohort. The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months post-randomization. Prespecified agency-specific definitions are used for the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events will be confirmed by a blinded Endpoint Adjudication Committee.

适应症

Rifampicin-Resistant Pulmonary TuberculosisMultidrug-Resistant Pulmonary Tuberculosis

主动联系研究团队

总联系人（申办方／研究总部）

中国／港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

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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: A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
ClinicalTrials.gov Identifier: NCT07209761
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigational product: Bedaquiline, Quabodepistat, Pretomanid, Moxifloxacin, Linezolid

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：A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
试验编号：NCT07209761
申办方：Otsuka Pharmaceutical Development & Commercialization, Inc.
研究药物：Bedaquiline、Quabodepistat、Pretomanid、Moxifloxacin、Linezolid

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 Otsuka-ProfessionalServices@otsuka-us.com

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