2024-514292-18-00招募中3 期
An Open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 22
- 主要终点
- Occurrence of Treatment emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate safety and tolerability of norucholic acid (NCA) film-coated tablets in the treatment of Primary Sclerosing Cholangitis (PSC).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •Males or females ≥ 18 years.
- •Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and • has completed the DBE phase with Visit 22, or • has prematurely terminated the DBE phase before this trial has been started, or • has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy* *Lack of efficacy as defined in the NUC-5/PSC trial
- •Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence (only accepted as a highly effective contraceptive measure if it is the usual and preferred lifestyle of the patient), throughout the treatment period and for four weeks following the last dose of study treatment. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the patient has this adequate birth control for study participation.
排除标准
- •History or presence of chronic alcoholic consumption (daily consumption > 30 g in men, > 20 g in women).
- •Abnormal renal function at screening
- •Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if fT4 is measured and within the normal range).
- •Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance, or any disorder which in the opinion of the investigator may affect the patient’s safety.
- •Any active malignant disease.
- •Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
- •Well-founded doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs.
- •Existing or intended pregnancy or breast-feeding.
- •Participation in another clinical trial (other than the NUC-5/PSC trial) within the last 30 days prior to screening visit, simultaneous participation in another clinical trial, or previous enrolment in this trial and intake of Investigational Medicinal Product (IMP) within this trial
- •Imprisoned persons, persons admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent (e.g. due to mental impairment).
- •Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
- •Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient’s safety.
- •Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).
结局指标
主要结局
Occurrence of Treatment emergent adverse events (TEAEs)
Occurrence of Treatment emergent adverse events (TEAEs)
Occurrence of Serious TEAEs
Occurrence of Serious TEAEs
Occurrence of Severe TEAEs
Occurrence of Severe TEAEs
Occurrence of Adverse Drug reactions (ADRs)
Occurrence of Adverse Drug reactions (ADRs)
Occurrence of Unexpected TEAEs
Occurrence of Unexpected TEAEs
次要结局
- (Safety) Changes from baseline in vital signs (blood pressure, heart rate) and body weight
- (Safety) Changes from baseline in hematology, serum chemistry (other than efficacy variables) and urinalysis
- (Efficacy) Course of liver stiffness
- (Efficacy) s-ALP in categories from baseline to EoT
研究者
CTIS – Scientific Request
Scientific
Dr. Falk Pharma GmbH
研究点 (22)
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