JPRN-jRCT2031210380已完成2 期
Phase II physician-initiated clinical trial investigating the efficacy and safety of guanabenz acetate for non-alcoholic fatty liver disease associated with hypertension (G-Flash study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
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 <= 75age old（—）
- 性别
- All
入选标准
- •1.Patients who have received a full explanation about this study and who have provided written consent.
- •2.Patients >= 20 years of age =< 75 years of age at the time consent was provided.
- •3.Patients diagnosed with essential hypertension and whose systolic blood pressure at the time of screening is >= 130 mmHg and/or diastolic blood pressure is >= 85 mmHg (according to the diagnostic criteria for metabolic syndrome)
- •4.Patients diagnosed with NAFLD/NASH who meet the following criteria (1) or (2)
- •(1) Patients diagnosed with NAFLD
- •(2) Patients with a definitive diagnosis of NASH by biopsy within 32 weeks before screening
- •5.Patients with magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) liver fat mass >= 8% at screening.
- •6.Patients with magnetic resonance elastography (MRE)value =< 3.6 kPa at screening.
- •7.Patients with a body mass index (BMI) >= 25 kg/m2 at the time of screening.
- •8.Patients receiving diet or exercise therapy 12 weeks before screening, with no improvement.
- •9.Patients who are willing to maintain a stable diet and physical activity during the clinical trial.
排除标准
- •1.Pregnant, lactating, potentially pregnant women, or patients who do not agree to contraception during the trial period.
- •2.Patients who have taken guanabenz acetate within 16 weeks prior to screening or who have participated in other clinical studies (observational studies are excluded).
- •3.Patients with drug allergies to guanabenz acetate.
- •4.Patients with liver failure or cirrhosis.
- •5.Patients with the following laboratory test values:
- •(1)Alanine aminotransferase (ALT) > 430 IU/L (males) or > 240 IU/L (female), or aspartate aminotransferase (AST) > 300 IU/L (males and females)
- •(2)Prothrombin time-international normalized ratio (PT-INR) >= 1.5 (excluding anticoagulant therapy)
- •(3)Total bilirubin value > 2.0 mg/dL (excluding definitive diagnosis of Gilbert syndrome)
- •(4)Platelet count < 80,000/uL
- •(5)Estimated glomerular filtration ratio (eGFR) < 45 (calculated by body surface area correction: standardized eGFR)
- •6.Patients with a history of acute or chronic liver disease other than NAFLD/NASH and complications:
- •(1)Patients suffering from hepatitis B (defined by hepatitis B surface (HBs) antigen positive at the time of screening) or hepatitis C (defined by hepatitis C virus (HCV) antibody positive at the time of screening). However, anti-HCV antibody positive patients who are judged to be negative for hepatitis C virus ribonucleic acid (HCV-RNA) can be registered if they can be confirmed to be negative for at least one year before screening.
- •(2)Patients with autoimmune hepatitis.
- •(3)Patients with primary biliary cholangitis, primary sclerosing cholangitis, Wilsons disease, alpha1-antitrypsin deficiency, hemochromatosis or iron overload, drug-induced or alcoholic liver disease, or a history of known biliary atresia.
- •(4)Patients with suspicion or definitive diagnosis of hepatocellular carcinoma.
- •7.Patients with a history of human immunodeficiency virus (HIV) infection.
- •8.Patients with findings of portal hypertension (complications: ascites, hepatic encephalopathy, varicose veins, splenomegaly).
- •9.Patients with a history of NAFLD-related drugs (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, higher doses of estrogen, anabolic steroids or valproic acid than used for hormone replacement) or other hepatotoxins for at least 4 weeks prior to screening.
- •10.Patients who have used the following drugs
- •(1)Patients who used insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, SGLT2 inhibitors, or thiazolidine 12 weeks before screening,
- •(2)Patients who used ursodeoxycholic acid or vitamin E 12 weeks before screening,
- •(3)Patients whose doses of dyslipidemia drugs or antihypertensive drugs were changed 12 weeks before screening,
- •(4)Patients whose dose of oral diabetes treatment drug (dipeptidyl peptidase 4 (DPP-4) inhibitor, sulfonylurea (SU) preparation, alpha-glucosidase inhibitor, metformin) was changed 12 weeks before screening,
- •(5)Patients who used drugs known to have a significant effect on body weight (including over-the-counter drugs for weight loss) 12 weeks before screening,
- •(6)Patients using central nervous system depressants (barbital, sodium thiopental, morphine hydrochloride hydrate, brotizolam, diazepam, etc.).
- •11.Patients with 10% weight change 24 weeks before screening.
- •12.Patients scheduled to undergo surgery after obesity surgery (such as gastroplasty and Roux-en-Y gastric bypass surgery) or during the trial period.
- •13.Patients with a history of type 1 diabetes.
- •14.Patients with hemoglobin A1c (HbA1c)
研究者
相似试验
进行中（未招募）
2 期
An investigator-initiated, phase II clinical trial of the peptide-based cancer vaccine targeting WT1, DSP-7888, for colorectal adenomas in familial adenomatous polyposisFAPfamilial adenomatous polyposisJPRN-jRCT2051200082Shichijo Satoki30
招募中
2 期
An investigator-initiated clinical trial of TM5614 for SSc-ILDInterstitial lung disease associated with systemic sclerosisD012595JPRN-jRCT2021230022Asano Yoshihide50
招募中
1 期
Phase I / IIa clinical study (FIH study) to investigate the safety and efficacy of high-purity mesenchymal stem cell (REC-01) transplantation in pediatric patients with hypophosphatasiasevere hypophosphatasiaJPRN-jRCT2063210019Taketani Takeshi3
招募中
2 期
Investigator-initiated clinical trial (Phase II) of cancer vaccine DSP-7888 for acute myeloid leukemia patients.Acute myeloid leukemiaD015470AMLJPRN-jRCT2051200023akata Jun100
已完成
不适用
An investigator initiated phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host diseaseRecipients refractory or resistant chronic GVHD to therapy with corticosteroidJPRN-UMIN000020363Okayama University Hospital18