NL-OMON55327已完成2 期
Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of Rhudex granules with placebo in the treatment of primary biliary cholangitis - RHUBY: RHUdex in primary BiliarY cholangitis
AML Clinical Services BV0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients who meet all of the following criteria can be enrolled into the trial:
- •1. Patient is able to understand the information on the trial and has signed
- •the informed consent form,
- •2. Male or female patients >= 18 and < 75 years,
- •3. PBC verified by at least 2 out of the following 3 criteria (consistent with
- •EASL practice guidelines [2017]) :
- •Chronic cholestatic disease (e.g. elevated serum ALP) of at least 6 months
- •Positive AMA titer or presence of PBC-specific antibodies,
- •Liver biopsy compatible with the diagnosis of non-cirrhotic PBC,
- •4. UDCA treatment for at least 6 months (with a stable dose for >= 3 months of
- •at least 12 mg/kg/day) prior to baseline,and no foreseen changes of the dosing
- •regimen throughout trial participation,
- •5. Inadequate response to UDCA treatment defined by serum ALP levels between
- •1.5x and 10x the upper limit of normal (ULN) at screening,
- •6. Women of childbearing potential agree to use during the entire duration of
- •the trial and until 4 weeks following the last dose of trial treatment a highly
- •effective method of birth control, defined as those which result in a low
- •failure rate (i.e. less than 1% per year) when used consistently and correctly
- •such as implants, injectables, combined oral contraceptive methods, some
- •intrauterine devices (IUDs), sexual abstinence, or vasectomised partner. Women
- •of non-childbearing potential (surgically sterile [e.g. hysterectomy, bilateral
- •salpingectomy, bilateral oophorectomy], or postmenopausal with at least 2 years
- •without spontaneous menses) may be included. The investigator is responsible
- •for determining whether the patient uses adequate birth control for trial
- •participation
排除标准
- •Patients who meet one or more of the following criteria are not allowed to be
- •enrolled into the trial:
- •1. History or presence of other relevant concomitant liver diseases including:
- •Positive hepatitis B or C serology: hepatitis B surface antigen (HBsAg+),
- •antibodies against hepatitis B core antigen (anti-HBc+), antibodies against
- •hepatitis C virus (anti-HCV+),
- •Note: Patients with anti-HBc+ only and negative hepatitis B virus
- •(HBV)-deoxyribonucleic acid (DNA) as well as patients with anti-HCV+ only and
- •negative HCV-ribonucleic acid (RNA) may be included
- •Primary Sclerosing Cholangitis,
- •Wilson*s Disease,
- •Haemochromatosis,
- •Current histologic and serologic evidence to support a clinical diagnosis of
- •concomitant autoimmune hepatitis requiring treatment,
- •Nonalcoholic steatohepatitis (NASH),
- •Alcoholic steatohepatitis (ASH),
- •Cholangiocarcinoma,
- •Drug-induced liver disease,
- •Suspected or proven liver cancer.
- •2. Treatment with any of the following drugs within the last 4 weeks prior
- •to screening: any glucocorticosteroids, azathioprine or other immunosuppressive
- •drugs (e.g. cyclophosphamide, cyclosporine, methotrexate, tacrolimus,
- •6-mercaptopurine, colchicine) orpentoxyfylline,
- •Note: Treatment with dermal, inhalative, or nasal topical glucocorticosteroids
- •for up to 10 days within the last 4 weeks prior to screening or as planned
- •concomitant treatment for up to 10 days/4 weeks is allowed.
- •3. Treatment with farnesoid X receptor-agonists and biologics (e.g. anti-TNF-a
- •therapy) within the last 8 weeks prior to screening,
- •4. Treatment with fibrates unless on stable dose for 8 weeks prior to screening
- •and no foreseen changes of the dosing regimen throughout trial participation,
- •5. Liver cirrhosis confirmed by an accepted diagnostic procedure (e.g.
- •histology, fibrosis-4 [FIB-4] score > 4.03, fibroscan >= 16.9 kPa ),
- •6. History or presence of hepatic decompensation (e.g. variceal bleeding
- •hepatic encephalopathy or poorly controlled ascites),
- •7. Serum albumin less than 3.2 g/dL, at screening,
- •8. Total bilirubin > 2x ULN, at screening,
- •9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5x ULN
- •at screening visit,
- •10. History of stroke or coronary artery disease,
- •11. History of sudden death or cardiovascular death before the age of 50 in any
- •first degree relative,
- •12. History or family history of hereditary clotting disorder,
- •13. Any known relevant infectious disease (e.g. active tuberculosis, acquired
- •immunodeficiency syndrome-defining diseases),
- •14. Abnormal renal function (glomerular filtration rate estimated from cystatin
- •C < 60 mL/min) at screening visit,
- •15. Thyroid-stimulating hormone > ULN at screening (elevated levels [4.2-10 µU/
- •mL] are acceptable if free thyroxine 4 is measured and within the normal range),
- •16. Current history of significant alcohol consumption (> 30 g/day in men, > 20
- •g/day in women on average) for a period of more than 3 consecutive months
- 另有 8 项未显示
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