EUCTR2009-017080-41-GB进行中（未招募）1 期
A randomised, partially-blind, placebo-controlled, pilot, dose-ranging study to assess the effect of cannabidiol (CBD) on liver fat levels in subjects with fatty liver disease.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subject is willing and able to give informed consent for participation in the study
- •Subject is aged 18 years or above
- •Subjects with a liver fat content of equal to or above 5% as measured by MRI/MRS or biopsy within two months of screening or willing to undergo an MRI/MRS scan at Visit 1to confirm a liver fat content of equal to or above 5%
- •In the opinion of the investigator, no changes in levels of exercise for four weeks and diet (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment and subject agrees to keep stable for the duration of the study
- •Subject is able (in the investigator’s opinion) and willing to comply with all study requirements
- •Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
- •Subject is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Clinical diagnosis or treatment for Type I / II diabetes
- •Subject has received an unapproved IMP within the 30 days prior to the screening visit
- •Currently receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study
- •Currently using or has used recreational cannabis, medicinal cannabis or cannabinoid medications (including Sativex®), within one month prior to study entry and unwilling to abstain for the duration for the study
- •Any known or suspected history of:
- •- alcohol or substance abuse
- •- epilepsy or recurrent seizures
- •Any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression – in the opinion of the investigator)
- •Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator
- •Known history of Hepatitis B or C
- •Genetic dyslipidaemia in the opinion of the investigator
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject’s ability to participate in the study
- •Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s)
- •Presence of any metal implants
- •Any known or suspected history of claustrophobia
- •Female subjects of child bearing potential not able or willing to use effective contraception for the duration of the study and for three months thereafter or male subjects whose partner is of child bearing potential, who are not willing to ensure that they or their partner use effective contraception during the study and for three months thereafter
- •Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
- •Weighing >150 kg
- •Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator would prevent the subject from safe participation in the study
- •Unwilling to abstain from donation of blood during the study
- •Travel outside the country of residence planned during the study
- •Subject has previously enrolled into this study.
研究者
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