KCT0012424进行中（未招募）不适用
Development of Indicator: Accurate MOdel of Noninvasive cfDNA in Pediatric Crohn’s Disease(PCD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort, Time Perspective : Prospective, Enrollment : 50, Biospecimen Retention : Not collect nor Archive
入排标准
- 年龄范围
- 6(Year) 至 18(Year)（—）
- 性别
- All
入选标准
- •Participants must meet all of the following criteria:
- •Male or female patients aged 6 to 18 years with moderate-to-severe Crohn's disease requiring infliximab treatment.
- •o Moderate-to-severe Crohn's disease is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) =30, according to the ECCO and ESPGHAN guidelines.
- •Biologic-naïve patients with no previous exposure to biologic agents.
- •Patients who have had an inadequate response to, are intolerant of, or have a contraindication to conventional therapies, including corticosteroids, immunomodulators, or exclusive enteral nutrition.
- •Written informed consent obtained from the parent(s) or legal guardian(s), and assent from the patient when applicable, prior to study participation.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •Patients who do not require infliximab therapy.
- •Patients younger than 6 years or older than 18 years of age.
- •History of hypersensitivity to infliximab or other humanized protein products.
- •Current systemic corticosteroid therapy, except for patients receiving corticosteroid tapering with the intention of discontinuation.
- •History of tuberculosis (TB).
- •o Patients with a previous history of TB may be enrolled if they have completed the minimum recommended anti-tuberculosis treatment according to current treatment guidelines and are considered by the investigator to have adequately completed therapy.
- •o TB screening may be performed using medical history together with either a tuberculin skin test (PPD) or an interferon-gamma release assay (IGRA).
- •Current or previous chronic hepatitis B or hepatitis C infection.
- •o Patients with screening results of HBsAg negative, HBsAb positive or negative, and HBcAb positive may be enrolled at the investigator's discretion.
- •Known HIV infection or positive HIV test.
- •New York Heart Association (NYHA) Class III or IV heart failure.
- •Active infection, current malignancy (except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix), or a history of colorectal or small intestinal dysplasia within the previous 5 years.
- •Any medical or other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
研究者
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