Portal HypertensionPhase 3NCT05227833
Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer
A Phase 3 study testing Vonoprazan fumarate (Vonaspire) and Pantoprazole 40mg in people with Portal Hypertension and Variceal Hemorrhage, run by Alexandria University at 1 site in Egypt.
Trial summary
Endoscopic variceal ligation (EVL) is used to control and prevent variceal bleeding in patients with liver cirrhosis, but it can be complicated by bleeding from post-EVL ulcers. the current study aims at evaluating the potential benefit of different acid-suppressive therapies in prevention of post band ligation… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension, Variceal Hemorrhage, Ulcer Hemorrhage
- What is being tested?
- Vonoprazan fumarate (Vonaspire) and Pantoprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 15 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients with liver cirrhosis with portal hypertension who are eligible for endoscopic band ligation (Bleeding varices, or non-bleeder but with risk signs) according to BAVINO VII guidelines
- Patients who completed the study protocol.
- Eligible participants who are willing to comply with the study protocol and provide written consent.
Who cannot join
- Endoscopically confirmed pre-existing esophageal ulcers
- Ongoing therapy with any anti-acid agent,
- Hepatocellular carcinoma
- Portal vein thrombosis
- Previous anti-flux procedure,
- Barrett's esophagus,
Show all 9Show fewer
- History of liver transplantation,
- Pregnancy, and allergy or past adverse reaction to acid-suppressive therapy
- Estimated glomerular filtration rate < 60 mL/min/1.73 meter square.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria Main University Hospital
Alexandria, Alexandria Governorate, 21521
About this study
Official title: Vonoprazan vs. Pantoprazole in the Prevention of Post Endoscopic Band Ligation Ulcer/Bleeding in Portal Hypertensive Patients: A Randomized Controlled Trial
Endoscopic variceal ligation (EVL) is used to control and prevent variceal bleeding in patients with liver cirrhosis, but it can be complicated by bleeding from post-EVL ulcers. the current study aims at evaluating the potential benefit of different acid-suppressive therapies in prevention of post band ligation ulcer/bleeding. We will include 234 patients with cirrhotic portal hypertension undergoing endoscopic band ligation. Patients will be randomly allocated into one group of acid suppressive therapy (Vonoprazan or pantoprazole) versus placebo for 14 days. Re-endoscopy will be done after 2 weeks of treatment to assess the healing of post ligation ulcers. Any form of upper gastrointestinal bleeding will be documented.
Read the detailed description
Patients with portal hypertension who have esophageal varices usually are treated by endoscopic band ligation according to the international guidelines to prevent variceal bleeding. After band ligation, patients may suffer from post-ligation ulcer and/or bleeding. In the current study, we evaluate the effectiveness of Vonoprazan, a novel potassium-competitive acid suppressor agent, in prevention of post-ligation ulcer and /or bleeding. We also will compare this drug with the proton-pump inhibitor Pantoprazole and with placebo. We aim to enroll 234 patients who will undergo elective endoscopic variceal ligation according to the BAVINO VII guidelines will be randomly assigned to one of three arms : Vonoprazan 20 mg once daily, Pantoprazole 40 mg once daily, or Placebo (no treatment). The treatment will start from the day of band ligation and will continue for 14 days. After that, a follow up endoscopy will be done to evaluate the site of band ligation. Any ulcer at the ligation site will be documented and its size will be measured. Also, any attack of bleeding from the ulcer site (if present) will be documented. A comparison between the three arms will be done in terms of effectiveness, and bleeding rates.
Safety assessment:
The safety assessment will include all patients who will receive at least 1 dose of their assigned treatment. The safety endpoints will include treatment related adverse effects (TRAEs) grouped by Medical Dictionary for Regulatory Activities version 19.1, system organ class and preferred term, and changes from baseline in an abbreviated physical examination including vital signs, signs of liver cell deterioration, and mean change in laboratory measures including hemogram, liver aminotransferases, serum urea and creatinine, liver function test.
- Conditions
- Portal Hypertension, Variceal Hemorrhage, Ulcer Hemorrhage
- Being tested
- Vonoprazan fumarate (Vonaspire), Pantoprazole 40mg, Placebo
- Keywords
- Portal Hypertension, Post-ligation ulcer, Vonoprazan, Pantoprazole, Variceal bleeding
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan fumarate (Vonaspire)Drug
Also called Vonoprazan
Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.
Pantoprazole 40mgDrug
Also called Pantoprazole Sodium
Patients assigned to Pantoprazole tablets (Controloc OR Antopral OR Perloc) will receive a daily dose of 40 mg before breakfast starting from the first day of band ligation.
PlaceboOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan | Experimental | Vonoprazan (vonaspire 20 mg), tablets, one tablet per day before breakfast for 14 days starting from the day of band ligation. Receives: Drug: Vonoprazan fumarate (Vonaspire) |
| Pantoprazole | Active comparator | Pantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets, one tablet per day before breakfast for 14 days, starting from the day of band ligation. Receives: Drug: Pantoprazole 40mg |
| Placebo | Placebo comparator | No acid suppressive medications will be described. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post ligation ulcer : presence (Yes or No), number, and size
- presence of post ligation ulcer (Yes/NO)
- the number of ulcers if present.
- the maximum dimension of an ulcer (if present) in millimeter.
Measured: At 2 weeks after intervention (EBL)
Post endoscopic variceal ligation ulcers
Number of participants who experienced post-ligation ulcer.
Measured: At 2 weeks after intervention
Post endoscopic variceal ligation bleeding
Number of participants who experienced post-ligation ulcer bleeding.
Measured: during the 2 weeks treatment duration
Secondary outcomes (1)
Number of participants with Vonoprazan-related adverse events as assessed by TRAEs grouped by Medical Dictionary for Regulatory Activities version 19.1
- The safety assessment will include all patients who will receive at least 1 dose of their assigned treatment.
- The safety endpoints will include treatment related adverse effects (TRAEs) grouped by Medical Dictionary for Regulatory Activities version 19.1, system organ class and preferred term, and changes from baseline in an abbreviated physical examination and laboratory parameters including:
- Vital signs,
- New onset hepatic encephalopathy,
- New onset ascites OR Increasing a pre-existing ascites,
- Changes in hemogram,
- Liver aminotransferases,
- Prothrombin time/INR
- Serum Bilirubin
- Serum urea and creatinine.
These data will be collected through:
- Recording the baseline clinico-laboratory parameters at the 1st visit
- Re-evaluation of the same parameters at 2 weeks follow-up visit
- Encouraging the patients to communication with the study team in case of any other adverse events that may occur during the treatment duration.
Measured: During the 2 weeks of medication use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Feb 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled participants after having an endoscopic variceal ligation session will be randomly allocated to one of three interventions (for 14 days): Vonoprazan 20 mg once before breakfast OR Pantoprazole 40 mg before breakfast OR Placebo (no treatment) at a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh A. Lashen, Alexandria University
- Investigators
- Sameh Lashen, MD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227833
- Sponsor's protocol ID
- 0305413
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2022
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang SH, Yim HJ, Kim SY, Suh SJ, Hyun JJ, Jung SW, Jung YK, Koo JS, Lee SW. Proton Pump Inhibitor Therapy Is Associated With Reduction of Early Bleeding Risk After Prophylactic Endoscopic Variceal Band Ligation: A Retrospective Cohort Study. Medicine (Baltimore). 2016 Feb;95(8):e2903. doi: 10.1097/MD.0000000000002903.
PubMed 26937932Lin L, Cui B, Deng Y, Jiang X, Liu W, Sun C. The Efficacy of Proton Pump Inhibitor in Cirrhotics with Variceal Bleeding: A Systemic Review and Meta-Analysis. Digestion. 2021;102(2):117-127. doi: 10.1159/000505059. Epub 2020 Feb 21.
PubMed 32088712
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonoprazan vs. Pantoprazole in the Prevention of Post Endoscopic Band Ligation Ulcer/Bleeding in Portal Hypertensive Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05227833
- Acronym / sponsor ID
- 0305413
- Conditions
- Portal Hypertension, Variceal Hemorrhage, Ulcer Hemorrhage
- Keywords
- Portal Hypertension, Post-ligation ulcer, Vonoprazan, Pantoprazole, Variceal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic variceal ligation (EVL) is used to control and prevent variceal bleeding in patients with liver cirrhosis, but it can be complicated by bleeding from post-EVL ulcers. the current study aims at evaluating the potential benefit of different acid-suppressive therapies in prevention of post band ligation ulcer/bleeding. We will include 234 patients with cirrhotic portal hypertension undergoing endoscopic band ligation. Patients will be randomly allocated into one group of acid suppressive therapy (Vonoprazan or pantoprazole) versus placebo for 14 days. Re-endoscopy will be done after 2 weeks of treatment to assess the healing of post ligation ulcers. Any form of upper gastrointestinal bleeding will be documented.
Detailed description
Patients with portal hypertension who have esophageal varices usually are treated by endoscopic band ligation according to the international guidelines to prevent variceal bleeding. After band ligation, patients may suffer from post-ligation ulcer and/or bleeding. In the current study, we evaluate the effectiveness of Vonoprazan, a novel potassium-competitive acid suppressor agent, in prevention of post-ligation ulcer and /or bleeding. We also will compare this drug with the proton-pump inhibitor Pantoprazole and with placebo. We aim to enroll 234 patients who will undergo elective endoscopic variceal ligation according to the BAVINO VII guidelines will be randomly assigned to one of three arms : Vonoprazan 20 mg once daily, Pantoprazole 40 mg once daily, or Placebo (no treatment). The treatment will start from the day of band ligation and will continue for 14 days. After that, a follow up endoscopy will be done to evaluate the site of band ligation. Any ulcer at the ligation site will be documented and its size will be measured. Also, any attack of bleeding from the ulcer site (if present) will be documented. A comparison between the three arms will be done in terms of effectiveness, and bleeding rates.
Safety assessment:
The safety assessment will include all patients who will receive at least 1 dose of their assigned treatment. The safety endpoints will include treatment related adverse effects (TRAEs) grouped by Medical Dictionary for Regulatory Activities version 19.1, system organ class and preferred term, and changes from baseline in an abbreviated physical examination including vital signs, signs of liver cell deterioration, and mean change in laboratory measures including hemogram, liver aminotransferases, serum urea and creatinine, liver function test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The enrolled participants after having an endoscopic variceal ligation session will be randomly allocated to one of three interventions (for 14 days): Vonoprazan 20 mg once before breakfast OR Pantoprazole 40 mg before breakfast OR Placebo (no treatment) at a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan | Experimental | Drug: Vonoprazan fumarate (Vonaspire)Vonoprazan (vonaspire 20 mg), tablets, one tablet per day before breakfast for 14 days starting from the day of band ligation. |
| Pantoprazole | Active comparator | Drug: Pantoprazole 40mgPantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets, one tablet per day before breakfast for 14 days, starting from the day of band ligation. |
| Placebo | Placebo comparator | Other: PlaceboNo acid suppressive medications will be described. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with liver cirrhosis with portal hypertension who are eligible for endoscopic band ligation (Bleeding varices, or non-bleeder but with risk signs) according to BAVINO VII guidelines
- Patients who completed the study protocol.
- Eligible participants who are willing to comply with the study protocol and provide written consent.
Key exclusion criteria (9 listed)
- Endoscopically confirmed pre-existing esophageal ulcers
- Ongoing therapy with any anti-acid agent,
- Hepatocellular carcinoma
- Portal vein thrombosis
- Previous anti-flux procedure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonoprazan fumarate (Vonaspire)Also: VonoprazanPatients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation. | Drug | Vonoprazan |
| Pantoprazole 40mgAlso: Pantoprazole SodiumPatients assigned to Pantoprazole tablets (Controloc OR Antopral OR Perloc) will receive a daily dose of 40 mg before breakfast starting from the first day of band ligation. | Drug | Pantoprazole |
| PlaceboNo Intervention | Other | Placebo |
Primary outcome
Post ligation ulcer : presence (Yes or No), number, and size
Time frame: At 2 weeks after intervention (EBL)
1. presence of post ligation ulcer (Yes/NO) 2. the number of ulcers if present. 3. the maximum dimension of an ulcer (if present) in millimeter.
Post endoscopic variceal ligation ulcers
Time frame: At 2 weeks after intervention
Number of participants who experienced post-ligation ulcer.
Post endoscopic variceal ligation bleeding
Time frame: during the 2 weeks treatment duration
Number of participants who experienced post-ligation ulcer bleeding.
1 secondary outcome
Number of participants with Vonoprazan-related adverse events as assessed by TRAEs grouped by Medical Dictionary for Regulatory Activities version 19.1
Time frame: During the 2 weeks of medication use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 26937932Kang SH, Yim HJ, Kim SY, Suh SJ, Hyun JJ, Jung SW, Jung YK, Koo JS, Lee SW. Proton Pump Inhibitor Therapy Is Associated With Reduction of Early Bleeding Risk After Prophylactic Endoscopic Variceal Band Ligation: A Retrospective Cohort Study. Medicine (Baltimore). 2016 Feb;95(8):e2903. doi: 10.1097/MD.0000000000002903.
- Results publication: PubMed 32088712Lin L, Cui B, Deng Y, Jiang X, Liu W, Sun C. The Efficacy of Proton Pump Inhibitor in Cirrhotics with Variceal Bleeding: A Systemic Review and Meta-Analysis. Digestion. 2021;102(2):117-127. doi: 10.1159/000505059. Epub 2020 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh Lashen, MD principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonoprazan fumarate (Vonaspire) and Pantoprazole 40mg in people with Portal Hypertension and Variceal Hemorrhage, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post ligation ulcer : presence (Yes or No), number, and size (time frame: At 2 weeks after intervention (EBL)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227833, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.