Non-variceal Upper Gastrointestinal BleedingNCT07776730
Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
A study testing Pantoprazole and Keverprazan in people with Non-variceal Upper Gastrointestinal Bleeding, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Acute non-variceal upper gastrointestinal bleeding (ANVUGIB) is a common medical emergency requiring hospitalization. The cornerstone of ANVUGIB management is effective gastric acid suppression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-variceal Upper Gastrointestinal Bleeding
- What is being tested?
- Pantoprazole and Keverprazan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 908 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants presented with hematemesis, melena, or other clinical manifestations suggestive of upper gastrointestinal bleeding within 5 days before screening.
- Participants have endoscopic confirmation of a non-variceal source of upper gastrointestinal bleeding.
- Participants are aged between 18 and 75 years.
- Participants who are willing to participate in this clinical trial and sign the written informed consent.
Who cannot join
- Participants have experienced failure of endoscopic hemostasis, rebleeding before randomization, or a requirement for immediate transcatheter arterial embolization or surgery at the time of eligibility assessment.
- Participants have an active malignancy or malignancy expected to interfere with survival, outcome assessment, treatment adherence, or follow-up.
- Participants have esophageal or gastric varices or portal hypertensive gastropathy identified during endoscopic examination.
- Participants who are unable to swallow the study medication.
- Participants have a history of partial or total gastrectomy, gastric bypass surgery, or other major surgery.
- Severe organ dysfunction, including any of the following: Severe hepatic or renal impairment; Unstable or severe cardiovascular, respiratory, neurological, or other systemic disease.
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- Zollinger-Ellison syndrome.
- Any contraindication to keverprazan or pantoprazole, including known hypersensitivity to either medication or any of their components.
- Pregnancy or lactation.
- Participation in another clinical study within 3 months before enrollment.
- Other situations considered by the investigator as unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area), Shenyang, Liaoning
Shenyang, Liaoning
Xingshun Qi, MD, 18909881019, xingshunqi@126.com
Ran Wang, 17790995989, wangran891017@163.com
About this study
Official title: Keverprazan Versus Pantoprazole for the Treatment of Acute Non Variceal Upper Gastrointestinal Bleeding: Protocol of a Prospective, Multicenter, Non Inferiority, Randomized Controlled Trial
Acute non-variceal upper gastrointestinal bleeding (ANVUGIB) is a common medical emergency requiring hospitalization. The cornerstone of ANVUGIB management is effective gastric acid suppression. Potassium-competitive acid blockers (P-CABs) represent a novel class of gastric acid secretion inhibitors, which can rapidly and consistently increase intragastric pH. Keverprazan, a novel P-CAB, has been shown to be effective in treating duodenal ulcers and erosive esophagitis. Herein, we have designed a multicenter randomized controlled trial (RCT) to determine whether keverprazan is noninferior to pantoprazole in preventing rebleeding after successful initial hemostasis in patients with ANVUGIB.
Read the detailed description
This is a non-inferiority, randomized controlled trial. A total of 908 patients will be enrolled and stratified into high- and low-risk bleeding groups according to the GBS. Patients in the high-risk group will continue to receive high-dose intravenous PPI at a dosage of 8mg/h for 72 hours; and then those without rebleeding during this period will be randomized. Patients in the low-risk group will directly randomized. Eligible patients will be randomly assigned in a 1:1 ratio to receive keverprazan or pantoprazole. The primary endpoint will be the 14-day incidence of rebleeding. Secondary endpoints will include 1) the proportion of patients receiving blood transfusion, 2) additional endoscopic hemostasis or surgical or radiologic intervention, 3) all-cause mortality, and 4) adverse events within 14 days.
- Being tested
- Pantoprazole, Keverprazan
- Keywords
- non-variceal upper gastrointestinal bleeding, proton pump inhibitors, potassium-competitive acid blockers, keverprazan, pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Participants will receive oral Pantoprazole 40 mg once daily for 14 days.
KeverprazanDrug
Participants will receive oral Keverprazan 20 mg once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Keverprazan group | Experimental | Participants will receive oral Keverprazan 20 mg once daily for 14 days. Receives: Drug: Keverprazan |
| Pantoprazole group | Active comparator | Participants will receive oral Pantoprazole 40 mg once daily for 14 days. Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rebleeding.
The proportion of patients who experience at least one episode of rebleeding after initial hemostasis from randomization up to Day 14. Rebleeding is defined as the recurrence of bleeding after initial hemostasis, including repeated hematemesis and/or melena, hemodynamic instability, or a decrease in hemoglobin of more than 2g/dL. The proportion will be calculated as the number of patients with rebleeding divided by the total number of patients assigned.
Measured: From randomization up to Day 14.
Secondary outcomes (4)
Proportion of patients receiving blood transfusion
The proportion of patients who receive at least one transfusion of red blood cells after randomization up to Day 14. The proportion will be calculated as the number of patients receiving blood transfusion divided by the total number of patients assigned.
Measured: From randomization up to Day 14.
Proportion of patients receiving endoscopic hemostasis, transcatheter arterial embolization, surgery for bleeding.
The proportion of patients who undergo at least one additional hemostatic intervention due to rebleeding after randomization up to Day 14. Additional hemostatic interventions include repeat endoscopic hemostasis, transcatheter arterial embolization, and surgery for rebleeding. The proportion will be calculated as the number of patients receiving at least one additional hemostatic intervention divided by the total number of patients assigned.
Measured: From randomization up to Day 14.
All-cause mortality
The proportion of patients who die from any cause after randomization up to Day 14. The proportion will be calculated as the number of patients who die from any cause divided by the total number of patients assigned.
Measured: From randomization up to Day 14.
Incidence of adverse events
The proportion of patients who experience at least one adverse event after randomization up to Day 14. The proportion will be calculated as the number of patients with at least one adverse event divided by the total number of patients assigned. Adverse events will be coded and classified according to the prespecified adverse-event assessment criteria in the study protocol.
Measured: From randomization up to Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-variceal Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 908 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776730
- Sponsor's protocol ID
- XHNKKY-ANVUGIB
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.
PubMed 33567467Mullady DK, Wang AY, Waschke KA. AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review. Gastroenterology. 2020 Sep;159(3):1120-1128. doi: 10.1053/j.gastro.2020.05.095. Epub 2020 Jun 20.
PubMed 32574620Barbu LA, Vasile L, Cercelaru L, Surlin V, Mogoanta SS, Mogos GFR, Tenea Cojan TS, Margaritescu ND, Buliman A. Non-Variceal Upper Gastrointestinal Bleeding: A Retrospective Cohort of 364 Cases, Historical Comparison, and Updated Management Algorithm. Life (Basel). 2025 Aug 20;15(8):1320. doi: 10.3390/life15081320.
PubMed 40868965Bai Y, Li ZS. [Standardize the diagnosis and treatment of acute non-variceal upper gastrointestinal bleeding based on the update guidelines]. Zhonghua Nei Ke Za Zhi. 2019 Mar 1;58(3):161-163. doi: 10.3760/cma.j.issn.0578-1426.2019.03.001. Chinese.
PubMed 30803170