NCT07205874招募中不适用
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Scheuer's criteria
研究概览
简要总结
The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:
• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Positive AMA (≥1:40 titer)
- •Persistently normal ALP
排除标准
- •Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis
- •Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids
- •Contraindications for liver biopsy
- •Concomitant debilitating disease or poor prognosis
- •Pregnancy
结局指标
主要结局
Scheuer's criteria
时间窗: Just once, at enrollment
Liver biopsy samples
次要结局
- Enhanced Liver Fibrosis (ELF) Score(Just once, at enrollment)
- Tumor Necrosis Factor-alpha (TNF-α)(Just once, at enrollment)
- Fibroblast Growth Factor 19 (FGF-19)(Just once, at enrollment)
- Cytokine Profiling (Interleukin-6, -12, -23)(Just once, at enrollment)
- Transforming Growth Factor-beta (TGF-β)(Just once, at enrollment)
研究者
María Dolores Martín Arranz, PhD
Head of department
Hospital Universitario La Paz
研究点 (1)
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