Phase II Clinical Study of Vonorasan Fumarate Injection in the Treatment of Peptic Ulcer Bleeding (NCT06783257) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Clinical Study of Vonorasan Fumarate Injection in the Treatment of Peptic Ulcer Bleeding
150 participantsStarted 2025-02
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. The classification of peptic ulcers according to Forrest is as follows: Ia, Ib, IIa, IIb. For multiple ulcers, the higher Forrest grade is used for determination. After confirming the ability to achieve hemostasis through endoscopic treatment, the following requirements for endoscopic treatment are as follows:
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy.
. 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)
. A history of drug abuse within the last 5 years;
. Receipt of live vaccines or attenuated live vaccines within 30 days prior to the first administration, or plans to receive vaccinations during the study period;
. Hemorrhagic shock (occurring during the screening period with systolic blood pressure \<90 mmHg and heart rate \>120 beats/min, accompanied by symptoms such as pallor, cold and clammy extremities, restlessness, or altered mental status) or requiring arterial catheter embolization or surgical intervention due to unsuccessful endoscopic treatment;
. Concurrent upper gastrointestinal bleeding from other causes or suspected gastric malignancy under endoscopy; There is a clear history of surgery to reduce gastric acid or a history of gastric surgery (including but not limited to partial gastrectomy, gastric plasty, vagotomy, excluding simple perforation suturing);