Evaluating the Clinical Efficacy and Safety of Luspatercept Combined With Thalidomide in the Treatment of β-TDT Patients
报名条件（概要）
- 年龄：18 Years – 75 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
研究药物 / 干预措施
Luspatercept combined with low-dose thalidomide、Luspatercept plus placebo
申办方
Rongrong Liu
研究简介（原文）
β-thalassemia is one of the most common inherited hemoglobinopathies worldwide and a major public health issue that severely impacts birth quality, human health, and social progress. Currently, there are limited clinical drugs specifically designed to treat patients with β-thalassemia. This clinical trial aims to evaluate the efficacy and safety of luspatercept combined with low-dose thalidomide compared with luspatercept alone in patients with thalassemia. Key questions to be answered include: * Does luspatercept combined with low-dose thalidomide reduce the transfusion burden in patients with β-thalassemia major? * What medical problems may occur when patients receive luspatercept combined with low-dose thalidomide? In this clinical trial, participants were randomly assigned in a 1:1 ratio to either an intervention group (luspatercept combined with low-dose thalidomide) or a control group (luspatercept combined with placebo) using a central randomization system. The clinical efficacy and safety of the two groups were evaluated. The primary outcome measure was the clinical efficacy of luspatercept combined with low-dose thalidomide in reducing the transfusion burden in patients with β-thalassemia major.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Rongrong Liuliurongrong@stu.gxmu.edu.cn+86 0771 5356510
中国／港澳台研究中心
- Liuzhou People's HospitalLiuzhou，Guangxi，China
- Liuzhou Workers' HospitalLiuzhou，Guangxi，China
- The First Affiliated Hospital of Guangxi Medical UniversityNaning，China
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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: Evaluating the Clinical Efficacy and Safety of Luspatercept Combined With Thalidomide in the Treatment of β-TDT Patients ClinicalTrials.gov Identifier: NCT07338344 Sponsor: Rongrong Liu Investigational product: Luspatercept combined with low-dose thalidomide, Luspatercept plus placebo 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：Evaluating the Clinical Efficacy and Safety of Luspatercept Combined With Thalidomide in the Treatment of β-TDT Patients 试验编号：NCT07338344 申办方：Rongrong Liu 研究药物：Luspatercept combined with low-dose thalidomide、Luspatercept plus placebo 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）
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