JPRN-jRCTs031200280招募中2 期
Randomized clinical trial of pemafibrate on the relative efficacy and safety evaluated in comparisonwith fenofibrate in patients with NAFLD and elevated triglyceride - PRESENT study
Iwaki Michihiro0 个研究点目标入组 360 人开始时间: 2020年12月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
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
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Outpatients whose ages are between 20 and 80 years old at the time of obtaining consent.
- •2.Patients with fatty liver diagnosed by histological examination within 1 year prior to obtaining consent, or by imaging examination within 6 months prior to obtaining consent, and who have not responded to exercise or diet therapy for more than 3 months
- •3. Patients with hypertriglyceridemia (150-500 mg / dl) within 91 days before obtaining consent.
- •4. Patients with high ALT (male 43-100 IU / L, female 24-100 IU / L) within 91 days before obtaining consent.
- •5.Patients whose daily drinking amount is less than 30 g per day for men and less than 20 g for women in terms of ethanol at the time of obtaining consent
- •6.Patients who do not have other liver diseases such as hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, and primary biliary cholangitis at the time of consent acquisition
- •7. Patients with written informed consent.
排除标准
- •1. Taking cyclosporine, rifampicin, amiodarone, and breast cancer treatments (tamoxifen, toremifene, raloxifene).
- •2. Patients with BMI <18.5kg/m2 at the time of consent.
- •3. Patients diagnosed with cirrhosis at the time of consent.
- •4. Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
- •5. Patients with T-Bil > normal upper limit x2 within 91 days before obtaining consent excluding Girbert syndrome.
- •6. Platelet count < 80,000 / uL within 91 days before obtaining consent.
- •7. Serum Cr level is 1.5 mg / dL or higher within 91 days before obtaining consent.
- •8. Patients with gallstones or biliary atresia at the time of consent.
- •9. Patients with severe infections, patients before and after surgery, patients with serious trauma at the time of consent,
- •10. Patients using fibrates within 91 days before obtaining consent.
- •11. Patients with a weight change of 10 % 91 days before obtaining consent.
- •12. Patients who have undergone or are planning bariatric surgery during the study period.
- •13. Patients with a history of type I diabetes.
- •14. Patients with HbA1c > 9.5 % within 91 days prior to obtaining consent.
- •15. Patients with psychosis, alcoholism, drug addiction, or drug addiction that may affect compliance with the research plan.
- •16. Patients who participated in other clinical trials 100 days before obtaining consent.
- •17. Pregnant women or patients who may be pregnant.
- •18. Patients with malignant tumor.
- •However, patients who have undergone radical surgery or who have completed administration of anticancer drugs are allowed to be registered, and patients who are being observed and evaluated for malignant tumors are excluded.
- •19. Patients who are considered inappropriate to participate in this study by the reseacher.
- •20. Patients who have received concomitant medications for more than 1 week.
研究者
相似试验
已完成
不适用
Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with untreated hypertriglyceridemiaHypertriglyceridemiaJPRN-UMIN000037026Sekino Hospital40
已完成
不适用
Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemiaHypertriglyceridemiaJPRN-UMIN000037110Sekino Hospital40
已完成
4 期
PALT02JPRN-jRCT2031200177Ishibashi Shun20
进行中（未招募）
不适用
Prospective randomised clinical trial on the fabrication of silicate ceramic crowns with two different impression systems, digital and conventional.Indication for a single-tooth crown reconstruction in the posterior region (premolar or molar)DRKS00025605ehr-, und Forschungsgebiet Computergestützte Zahnmedizin Klinik für Zahnärztliche Prothetik und Biomaterialien des Universitätsklinikums Aachen2
招募中
不适用
Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)JPRN-UMIN000035248Shinshu University School of Medicine20