Study for efficacy of DL-alanine in patients with primary sclerosing cholangitis (Study for efficacy of DL-alanine)

未提供0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年10月21日

适应症

试验速览

暂无简介。

•1.Patients with PSC who meets all following conditions.
•2.Patients within Child-Pugh score 6 during outpatient visits.
•3.Serum alkaline phosphatase exceeds the upper limit of normal despite taking ursodeoxycholic acid (UDCA) 600 mg/day or more for 4 weeks.
•Complicated with ulcerative colitis
•Patients who are 20 years of age or older at the time of consent, and who have given their written consent.

•Noncompensated liver cirrhosis with a Child Pugh classification of 7 or higher (B)
•Common bile duct stones, severe bile duct stricture, or bacterial cholangitis requiring endoscopic intervention.
•Concomitant or pre-existing malignancy.
•Ulcerative colitis classified as severe or fulminant.
•History of adverse reaction or allergy to this reagent.
•Patients with serious infectious diseases.
•With serious cardiac disease.
•With a serum creatinine level of 2.0 mg/dl or higher.
•Pregnant women or who may be pregnant, lactating, or wishing to become pregnant during the study period.
•Other patients deemed inappropriate for inclusion in the study by the investigator. 11.Exclusion criteria for concomitant medications. (1) Patients who have received antibiotic therapy within 2 weeks prior to enrollment. (2) Patients treated with steroids within 2 weeks prior to enrollment. (3) Patients who have been treated with biological agents for ulcerative colitis.(4) Patients may or may not have been treated with bezafibrate or 5-ASA.

Percentage change of serum ALP levels

发起方

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