NCT00004762已完成2 期
Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
National Center for Research Resources (NCRR)0 个研究点目标入组 5 人开始时间: 1994年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
OBJECTIVES:
I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
详细描述
PROTOCOL OUTLINE:
Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Stage I-III primary sclerosing cholangitis
- •Radiologically and pathologically documented
- •No concomitant liver disease, e.g.:
- •Viral hepatitis
- •Autoimmune hepatitis
- •Primary biliary cirrhosis
- •Cirrhosis
- •Portal hypertension or associated complications
- •Jaundice caused by dominant stricture
- •-Prior/Concurrent Therapy--
- •No concurrent immunosuppressives
- •-Patient Characteristics--
- •Hematopoietic:
- •Absolute neutrophil count at least 2500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 10 g/dL
- •No active infection
- •No fistula abscess
- •No active inflammatory bowel disease
- •Quiescent disease allowed, including: Chronic ulcerative colitis Crohn's disease
- •No other significant immunologic disorder
- •No active malignancy
- •No active alcohol or drug abuse
- •No pregnant or nursing women
- •Effective contraception required of fertile patients
- •Endoscopic retrograde cholangiopancreatography within 36 months prior to registration
- •Liver biopsy within 12 months prior to registration
排除标准
- 未提供
研究者
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