EUCTR2007-002114-19-GB进行中（未招募）不适用
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- 性别
- All
入选标准
- •Inclusion Criteria Part 1
- •1. Subject has signed written informed consent prior to screening
- •2. Subject is male or female and 18 years of age or above
- •3. For Part 1a: Subject has NASH, fibrosis stage F3 (zone 3 perisinusoidal / pericellular
- •fibrosis and portal fibrosis with focal or extensive bridging fibrosis) histologically
- •confirmed by a liver biopsy performed within 1 year prior to first dose.
- •For Part 1b:
- •Subject has NASH, fibrosis stage F0 - F3, histologically confirmed by a liver biopsy
- •performed within 1 year prior to randomization
- •4. Subject has serum ALT levels at screening below 300 U/l according to central laboratory analysis
- •5. Subject has had elevated serum ALT levels on two occasions tested within 1 year prior to screening according to local laboratory normal ranges.
- •Inclusion Criteria Part 2
- •1. Subject has signed written informed consent prior to screening
- •2. Subject is male or female and 18 years of age or above
- •3. Subject has NASH, fibrosis stage F0 - F3, histologically confirmed by a liver biopsy
- •performed within 1 year prior to randomization
- •4. Subject has elevated serum ALT levels at screening of at least 1.5x the upper limit of
- •normal range with a maximum of 300 U/l according to central laboratory analysis
- •5. Subject has had elevated serum ALT > 1.5 ULN or > 60 IU/L (local laboratory) on one occasion in the past 6 months and no documented normal value in the past year
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject is diagnosed with hepatic cirrhosis
- •2. Subject has confirmed positive HCV and / or positive HBV serology
- •3. Subject has known genetic or secondary hemochromatosis
- •4. Subject has other known cause of liver disease (autoimmune, viral, genetic, drug induced, alcoholic liver disease or storage disease) or drug-induced hepatotoxicity
- •5. Subject has an unstable metabolic condition i.e.; weight change > 5% in the 6 months prior to screening and / or diagnosis of diabetes mellitus type 2 within 4 months prior to screening and / or initiation and subsequent continuous use of anti-diabetic drugs (including insulin sensitizing agents), anti-hypertensives and/or lipid lowering drugs within 4 months prior to screening
- •6. Subject has uncontrolled diabetes mellitus type 2, i.e. HbA1c > 8.5%
- •7. Subject suffers from clinically significant gastrointestinal disease, or has a history of inflammatory bowel disease (Crohn’s disease, ulcerative colitis and undetermined inflammatory colitis) or has a currently symptomatic gastric ulcer or erosive gastritis
- •8. Irritable bowel syndrome
- •9. Subject has known lipodystrophy
- •10. Subject has had a malignancy in the last 10 years, except for adequately treated basal or squamous cell carcinoma of the skin
- •11. Subject has known HIV infection
- •12. Subject has had previous bowel resection
- •13. Subject has a positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination
- •14. Subject has any other disorder that is uncontrolled by therapy and clinically significant as deemed relevant by the investigator
- •15. Subject has a history of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than
- •30 g/day (3 units) for males
- •16. Female subject is pregnant, lactating or pre-menopausal with positive serum pregnancy test (hCG) or has an intention of becoming pregnant and / or does not use a medically acceptable method of birth control.**
- •17. Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)
- •18. Subject has used other PDE4 inhibitors within 6 months prior to screening
- •19. Subject started or changed the dose of one or more of the following drugs / food supplements within 1 month before randomization: insulin sensitizing agents (e.g.
- •biguanides, thiazolinediones), ursodeoxycholic acid, anti-obesity drugs (e.g. orlistat,
- •sibutramin, rimonabant), pentoxifylline, phosphatidylcholin, ginseng, selenium, vitamin
- •C, vitamin E
- •20. Subject uses concomitant medications which are mainly metabolized by CYP2C8/9 and which have a narrow safety margin (warfarin, phenytoin, paclitaxel and tolbutamide)
研究者
相似试验
进行中（未招募）
不适用
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTERon-alcoholic Steatohepatitis (NASH)MedDRA version: 9.1Level: LLTClassification code 10053219Term: Non-alcoholic steatohepatitisEUCTR2007-002114-19-BEAstellas Pharma Europe B.V.105
进行中（未招募）
1 期
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTEREUCTR2007-002114-19-FRAstellas Pharma Europe B.V.99
进行中（未招募）
不适用
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTEREUCTR2007-002114-19-DEAstellas Pharma Europe B.V.105
进行中（未招募）
不适用
A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH) - ASTEREUCTR2007-002114-19-CZAstellas Pharma Europe B.V.105
进行中（未招募）
1 期
A phase II, double-blind, randomized, parallel-group, placebocontrolled multi-center study to investigate the effect of the adenosine A1 receptor antagonist PBF-680 on forced expiratory volume in 1 second (FEV1) in patients with mild-to-moderate persistent atopic asthmapatients with mild-to-moderate persistent atopic asthmaMedDRA version: 20.0Level: LLTClassification code 10003638Term: Atopic asthmaSystem Organ Class: 100000004855EUCTR2017-003663-35-ESPalobiofarma S.78