Cirrhoses, LiverPhase 2NCT07267260
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
A Phase 2 study testing Vonoprazan 20 mg in people with Cirrhoses, Liver, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhoses, Liver
- What is being tested?
- Vonoprazan 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2025to 5 Mar 2026
- Phase
- Phase 2
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
- Adults aged 18 to 75 years (male or female)
- Diagnosis of liver cirrhosis confirmed by clinical, biochemical, or imaging findings.
- Presence of documented esophageal varices requiring endoscopic variceal band ligation (EVBL).
- Able and willing to provide written informed consent in English or Urdu.
- Willing to comply with study procedures, including taking study medication and attending follow-up endoscopy.
Who cannot join
- History of gastric or esophageal surgery
- Allergy or contraindication to vonoprazan or study drug components
- Pregnant or lactating women
- Individuals who are non-cooperative or unable to understand local languages
- Critically ill patients, including:
- ICU admission Requirement for mechanical ventilation GCS < 10
- Active gastrointestinal bleeding at the time of enrollment
- Malignancy of the upper gastrointestinal tract
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University/Mayo Hospital
Lahore, Punjab Province, 54000
Muhammad Sheikh, 03219994005, dr.usheikh@gmail.com
About this study
The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure.
The study will also look at how well vonoprazan is tolerated and if it improves comfort after the procedure.
Read more
The main questions this study will answer are:
Does vonoprazan lower the number and severity of ulcers found on endoscopy after EVBL?
Does vonoprazan reduce swallowing pain or chest discomfort compared with placebo?
Is vonoprazan safe and well tolerated in people with liver cirrhosis?
Researchers will compare vonoprazan 20 mg once daily with a placebo (a look-alike tablet that contains no active medicine) to see if vonoprazan works better to prevent these ulcers.
Participants will:
Take vonoprazan or placebo by mouth once daily for 14 days after EVBL.
Return for a follow-up endoscopy about two weeks later to check for ulcers.
Report any symptoms such as pain, nausea, or swallowing difficulty during the study.
Adults aged 18 to 75 years with liver cirrhosis who undergo EVBL will be invited to join. Participants will be randomly assigned to one of two groups, and neither they nor the study doctors will know which treatment they receive (double-blind design).
The study will take place at Mayo Hospital, Lahore, Pakistan, over about six months.
By comparing vonoprazan to placebo, researchers hope to find a better way to protect the esophagus and stomach after EVBL, reduce post-procedure pain, and support faster recovery in people with liver cirrhosis.
- Conditions
- Cirrhoses, Liver
- Being tested
- Vonoprazan 20 mg, Placebo
- Keywords
- Vonoprazan, Potassium-competitive acid blocker, Endoscopic variceal band ligation, Esophageal varices, Post-procedure ulcer, Cirrhosis, Portal hypertension, Double-blind randomized controlled trial
- Medical subject headings
- Esophageal and Gastric Varices, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan 20 mgDrug
Also called Potassium-competitive acid blocker, TAK-438
Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides strong and sustained suppression of gastric acid secretion. In this study, participants will receive vonoprazan 20 mg by mouth once daily for 14 days after endoscopic variceal band ligation (EVBL). The tablets will be taken with water, preferably before breakfast. This dose and duration are based on prior clinical experience in acid-related disorders. The aim is to determine whether vonoprazan prevents the formation of ulcers and reduces post-procedure pain compared with placebo.
PlaceboOther
Also called Inactive tablet
Participants in the placebo group will receive a look-alike oral tablet with no active medicine, once daily for 14 days after EVBL. The placebo will be identical in color, size, and packaging to the Vonoprazan tablet to maintain blinding. This comparator will help determine whether Vonoprazan provides any true benefit in preventing ulcers and improving symptoms beyond standard post-procedure care.
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan 20 mg after EVBL | Experimental | Participants in this arm will receive vonoprazan 20 mg orally once daily for 14 days following endoscopic variceal band ligation (EVBL). Vonoprazan is a potassium-competitive acid blocker that provides strong and sustained suppression of gastric acid. The aim is to test whether vonoprazan can help prevent the formation of ulcers that sometimes develop after EVBL and to improve symptoms such as pain or difficulty swallowing. Participants will continue their usual medical care for liver disease. Study staff, participants, and investigators will all remain blinded to treatment allocation until data analysis is complete. Receives: Drug: Vonoprazan 20 mg |
| Placebo after EVBL | Placebo comparator | Participants in this arm will receive a placebo tablet orally once daily for 14 days following endoscopic variceal band ligation (EVBL). The placebo tablet will look identical to the Vonoprazan tablet but contains no active medicine. This group serves as a comparison to determine whether Vonoprazan is more effective than placebo in preventing post-procedural ulcers and reducing symptoms such as swallowing discomfort or chest pain. Participants will receive standard medical care for liver disease and will undergo the same follow-up and assessments as the experimental group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers
The proportion of participants who develop visible post-banding ulcers detected on follow-up endoscopy. Ulcers will be assessed using the Lanza Score for gastric mucosal injury, which grades the number and severity of ulcers from 0 (no injury) to 4 (severe injury). A lower Lanza score indicates less mucosal injury. The outcome compares the rate and severity of ulcers between the vonoprazan and placebo groups.
Measured: At follow-up endoscopy, 14 ± 1 days after EVBL.
Secondary outcomes (1)
Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS)
Change in symptom intensity for swallowing pain (odynophagia), difficulty swallowing (dysphagia), and chest discomfort (retrosternal pain), measured using a 100 mm Visual Analog Scale (VAS) where 0 = no pain and 100 = worst possible pain. The change from baseline to day 14 will be calculated. A ≥ 20% reduction in VAS score from baseline will be considered clinically significant.
Measured: Baseline and 14 ± 1 days after EVBL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start16 Dec 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhoses, LiverStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizwan Tariq Neuro, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267260
- Sponsor's protocol ID
- 640/RC/KEMU Dated: 28/08/25
- Other IDs
- 640/RC/KEMU
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly because this is a single-center academic study conducted at Mayo Hospital, Lahore, with a limited sample size and locally collected data. De-identified summary data and statistical analyses may be made available upon reasonable request to the principal investigator after publication of study results, in accordance with institutional and ethical committee policies.