A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding
Voluntarily participate and sign the informed consent form.
Individuals aged between 18 and 75 years, regardless of gender.
Clinical manifestations of upper gastrointestinal bleeding, such as hematemesis, melena, or positive fecal occult blood, within 48 hours prior to screening.
Patients diagnosed with upper gastrointestinal bleeding caused by gastric and/or duodenal ulcers through endoscopic examination within 24 hours prior to random group selection, with ulcer maximum diameter ranging from 3 to 20 mm.
Individuals with a clinically significant history of drug allergies or known allergies to the components and excipients of the study drug;
Subjects with other severe central nervous system, cardiovascular, respiratory, organ, renal, gastrointestinal, urinary, endocrine, or hematological diseases, which the investigator believes may confound the study results or affect the safety of the subjects;
Hematological disorders: ① Platelet count <80×10^9/L; ② PT exceeds the upper limit of normal by 3 seconds; ③ APTT exceeds the upper limit of normal by 10 seconds; (If any of these criteria are met, the patient is not eligible for selection)
Renal function abnormalities: ① ALT or AST ≥1.5×ULN; ② Total bilirubin >1.5×ULN; ③ Serum creatinine (Cr) > ULN; (If any of these criteria are met, the patient is not eligible for selection)