Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
| Заболевание | Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis |
|---|---|
| Фаза | Фаза 2/3 |
| Спонсор | Galectin Therapeutics Inc. |
| Статус | Прекращено |
| Участники | 357 участн. |
| Вмешательство | belapectin |
| Дата начала | 25.06.2020 |
| Дата завершения | 11.03.2025 |
| Публикация результатов | 30.06.2026 |
Кратко
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 |
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- 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)