EUCTR2021-001431-56-NO进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Signed informed consent,
- •Male or female patients = 18 and = 74 years at screening,
- •PBC verified by at least 2 out of the following 3 criteria at screening:
- •- Chronic cholestatic disease of at least 12 months duration,
- •- Positive anti-mitochondrial antibody (AMA) titer or, if AMA negative or in low titer (< 1:80), presence of PBC-specific antibodies (anti-GP210 and/or
- •anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]),
- •- Liver biopsy available for review and compatible with the diagnosis of non-cirrhotic PBC,
- •Ursodeoxycholic acid (UDCA) treatment for at least 12 months (with a stable dose for = 3 months) prior to screening,
- •Women of childbearing potential agreeing to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment, 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 (IUD), sexual abstinence, or vasectomized partner. Women of non-childbearing potential (surgically sterile [e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy], or postmenopausal with at least two years without spontaneous menses) may be included. The investigator is responsible for determining whether the patient has adequate birth control for trial participation.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •History or presence of any other relevant concomitant liver diseases.
- •Patients taking prohibited medications
- •Liver cirrhosis. NOTE: Patients with compensated cirrhosis and a Child-Pugh Score <8 are allowed to participate,
- •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 < 30 ml/min) at screening visit,
- •Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated < 3 years before screening,
- •Existing or intended pregnancy or breast-feeding
研究者
相似试验
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisPrimary biliary cholangitisMedDRA version: 20.0Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-001961-34-ITDR. FALK PHARMA GMBH136
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisPrimary biliary cholangitisMedDRA version: 21.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-001961-34-HUDr. Falk Pharma GmbH136
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of norursodeoxycholic acid tablets with placebo in the treatment of non-alcholic fatty liver disease with liver inflammation (non-alcoholic steatohepatitis[NASH])on-alcoholic steatohepatitis (NASH)MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2018-003443-31-HUDr. Falk Pharma GmbH363
进行中（未招募）
1 期
Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery techniqueEUCTR2018-002617-35-DEDr. Falk Pharma GmbH90
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisPrimary biliary cholangitisMedDRA version: 21.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-001961-34-BEDr. Falk Pharma GmbH136