Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC

Dr. Falk Pharma GmbH0 个研究点目标入组 136 人开始时间: 2020年10月23日最近更新: 2021年3月22日

适应症

试验速览

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•- Patient is able to understand the information on the trial and has signed the informed consent form,
•- Male or female patients = 18 and < 75 years,
•- 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 duration,
•Positive AMA titer or presence of PBC-specific antibodies,
•Liver biopsy compatible with the diagnosis of non-cirrhotic PBC,
•- 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
•- Inadequate response to UDCA treatment defined by serum ALP levels between 1.5x and 10x the upper limit of normal (ULN) at screening,
•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 106
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- History or presence of other relevant concomitant liver diseases
•- Liver cirrhosis
•- History or presence of hepatic decompensation (e.g. variceal bleeding hepatic encephalopathy or poorly controlled ascites),
•- Serum albumin less than 3.2 g/dL, at screening,
•- Any known relevant infectious disease (e.g. active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases),
•- Abnormal renal function (glomerular filtration rate estimated from cystatin C < 60 mL/min) at screening visit,
•- Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if free thyroxine 4 (fT4) is measured and within the normal range),
•- 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 within 1 year prior to screening,
•- Any illness or medical conditions that are unstable or could jeopardise the safety of the patient and his/her compliance in the trial or might interfere with the trial results,
•- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated < 3 years before trial entry,
•- Existing or intended pregnancy or breast-feeding.

发起方