Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

NCT05227833 | Completed Phase 3 DMC

• 1 other identifier: 0305413
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Portal Hypertension; Variceal Hemorrhage; Ulcer Hemorrhage

Keywords

Portal Hypertension; Post-ligation ulcer; Vonoprazan; Pantoprazole; Variceal bleeding

Outcome Measures

Primary Outcomes (3)

• Post ligation ulcer : presence (Yes or No), number, and size

  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.

  At 2 weeks after intervention (EBL)

• Post endoscopic variceal ligation ulcers

  Number of participants who experienced post-ligation ulcer.

  At 2 weeks after intervention

• Post endoscopic variceal ligation bleeding

  Number of participants who experienced post-ligation ulcer bleeding.

  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

  During the 2 weeks of medication use

Study Arms (3)

Vonoprazan

EXPERIMENTAL

Vonoprazan (vonaspire 20 mg), tablets, one tablet per day before breakfast for 14 days starting from the day of band ligation.

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.

Drug: Pantoprazole 40mg

Placebo

PLACEBO COMPARATOR

No acid suppressive medications will be described.

Other: Placebo

Interventions

Vonoprazan fumarate (Vonaspire) DRUG

Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.

Also known as: Vonoprazan

Vonoprazan

Pantoprazole 40mg DRUG

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.

Also known as: Pantoprazole Sodium

Pantoprazole

Placebo OTHER

No Intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Alexandria University Hospital, Alexandria, Alexandria Governorate, Egypt: collaborator

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21521, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26937932 BACKGROUND

• Lin 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.

  PMID: 32088712 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Pantoprazole

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sameh Lashen, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single blinded design
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: February 15, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)