Upper gastrointestinal bleeding due to peptic ulcer
Conditions
Interventions
Positive control (ESO group):According to the administration reguirements of the study protocol, theexperimental group was treated with H008 injection, and the control group was
Experimental group:According to the administration reguirements of the study protocol, theexperimental group was treated with H008 injection, and the control group was
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1? 18 years old to 75 years old, gender not limited; 2?Within 48 hours before screening, there are symptoms and signs of upper gastrointestinal bleeding, such as hematemesis, melena, hematochezia, and/or signs of peripheral circulatory failure (such as dizziness, palpitations, pale complexion, increased heart rate, decreased blood pressure, etc.); 3?For those diagnosed with upper gastrointestinal bleeding caused by peptic ulcers by endoscopic examination within 24 hours before random enrollment, the maximum diameter of the ulcers ranged from 3 to 20 mm; 4?The Forrest grades of peptic ulcers are IA, IB, IIA, and IIB. For multiple ulcers, the higher Forrest grade is used for determination. After successful hemostasis is confirmed through endoscopic treatment, the requirements for endoscopic treatment are as follows: (1)For Forrest Ia, Ib and IIA patients: Heat coagulation hemostasis or mechanical hemostasis are the main methods. It is also allowed to combine other hemostasis methods on the basis of the aforementioned main means, such as local injection of norepinephrine saline, hypertonic sodium-epinephrine solution, etc. (2)For Forrest IIb: To confirm the specific classification, it is necessary to first attempt to rinse the attached blood clots under endoscopy. If the blood clot is cleared, the Forrest grade will be re-evaluated. If it is Forrest Ia, Ib, or IIA, endoscopic hemostasis treatment will be carried out as per the above requirements. If the blood clot is not cleared and is finally confirmed as Forrest IIb, direct enrollment is allowed. 5?Fully understand the content of the trial, voluntarily participate in the trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1?Those who are known to have a history of allergy to potassium-competitive acid blockers (including but not limited to vonolassen, tegolassen, kaiprasen, etc.), proton pump inhibitors (including but not limited to esomeprazole, omeprazole, etc.), other benzimidazole compounds or any other components of the investigational drug; 2?Those who have hemorrhagic shock or whose endoscopic treatment is unsuccessful and require ductal embolization or surgical treatment; 3?Those with upper gastrointestinal bleeding caused by other reasons or suspected gastric malignant tumors under endoscopy at the same time; 4?Those who have undergone gastrectomy, gastroenterostomy, or enterostomy; 5?Coagulation dysfunction (platelet count = twice the upper limit of normal values, total bilirubin > twice the upper limit of normal values, Cr > 1.5 times the upper limit of normal values); 7?At the time of screening, the subjects were accompanied by other serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, and the researchers believed that it might confuse the research results or affect the safety of the subjects; 8?Those with a history of malignant tumors within the previous 5 years (if the subject's basal cell carcinoma of the skin, carcinoma in situ of the cervix or thyroid cancer has been cured, he/she can participate in this study); 9?Have used ilaprazole sodium within 24 hours before signing the informed consent form, or have used other acid-suppressing drugs, somatostatin or other hemostatic drugs except ilaprazole sodium within 12 hours before signing the informed consent form (except for hemostatic drugs used under gastroscopy and topical hemostatic drugs); 10?Those who used PPIs, P-CAB preparations, H2 receptor antagonists, somatostatin, and hemostatic drugs (except for hemostatic drugs used under endoscopy and topical hemostatic drugs) from endoscopic treatment/intervention to the first administration of the investigatory drug; 11?During the trial period, drugs that interfere with the judgment of therapeutic effect may need to be used in combination, including somatostatin; Other PPIs or potassium-competitive acid blockers (P-CABs) : omeprazole, rabeprazole, pantoprazole, vonoprazine, etc. (except for investigative drugs and continued oral medication treatment); H2 receptor antagonists (ranitidine, cimetidine, famotidine, etc.); Gastrointestinal mucosal protectants (such as sucralfate tablets, etc.); Acidulants (sodium bicarbonate, etc.) Anticoagulants (such as heparin, warfarin, vitamin K antagonists, etc.); Antiplatelet drugs (aspirin, clopidogrel, etc.); Hemostatic drugs (such as hemostatic aromatic acid, hemostatic amine, Lihemostatic, Yunnan Baiyao and thrombin, etc., except for topical hemostatic drugs); Systemic glucocorticoids and non-steroidal anti-inflammatory drugs (except for local use); 12?Female subjects who are suspected of or already pregnant, breastfeeding, or preparing to become pregnant during the trial. According to the judgment of the researchers, women and male subjects of childbearing age who could not use medically recognized reliable contraceptive methods for contraception within 4 weeks from the signing of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of no rebleeding within 72 hours after the initiation of administration (endoscopic evaluation); | — |
Countries
China
Contacts
Public ContactXiaohua Hou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed