Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
| 适应症 | Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis |
|---|---|
| 分期 | 2/3期 |
| 申办方 | Galectin Therapeutics Inc. |
| 状态 | 提前终止 |
| 受试者人数 | 357 人 |
| 干预（药物） | belapectin |
| 开始日期 | 2020年6月25日 |
| 完成日期 | 2025年3月11日 |
| 结果公布日 | 2026年6月30日 |
摘要
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.
Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo
| Placebo | 56 Participants |
|---|---|
| Belapectin 2 mg/kg Lean Body Mass (LBM) | 45 Participants |
| Belapectin 4 mg/kg Lean Body Mass (LBM) | 51 Participants |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatoh — Akero Therapeutics, Inc
- Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease — Wake Forest University Health Sciences
- Effect of Obesity on Proton Pump Inhibitors — Children's Mercy Hospital Kansas City
- Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatoti — Merck Sharp & Dohme LLC
- Phase 2a Study of HPG1860 in Subjects With NASH — Hepagene (Shanghai) Co., Ltd.
- Vitamin E Dosing Study — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)