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正在招募I 期编号 NCT06298071

A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

报名条件（概要）

  • 年龄：18 Years – 70 Years
  • 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

药品与企业信息

SIBP-R002药物

其他名称：Peguricase for injection

Injection; strength: 4mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

SIBP-R002药物

其他名称：Peguricase for injection

Injection; strength: 8mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

SIBP-R002药物

其他名称：Peguricase for injection

Injection; strength: 12mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

Methotrexate药物

Combination drugs: Methotrexate, dose15 mg, oral.

研发企业

Shanghai Institute Of Biological Products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

Methotrexate

Hospira, Inc.

合作机构

  • The First Affiliated Hospital of Bengbu Medical University研究机构/其他
  • The First Affiliated Hospital of Henan University of Science and Technology研究机构/其他

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）

To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.

适应症

Gout

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

管理档案

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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 Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
ClinicalTrials.gov Identifier: NCT06298071
Sponsor: Shanghai Institute Of Biological Products
Investigational product: SIBP-R002, SIBP-R002, SIBP-R002, Methotrexate

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 Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
试验编号：NCT06298071
申办方：Shanghai Institute Of Biological Products
研究药物：SIBP-R002、SIBP-R002、SIBP-R002、Methotrexate

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 ddchen.sh@sinopharm.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