Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 2:03 AM
Study NCT ID:
NCT05227833
Status:
COMPLETED
Last Update Posted:
2024-08-30
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'single blinded design'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The enrolled participants after having an endoscopic variceal ligation session will be randomly allocated to one of three interventions (for 14 days):\n\nVonoprazan 20 mg once before breakfast OR Pantoprazole 40 mg before breakfast OR Placebo (no treatment) at a 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post ligation ulcer : presence (Yes or No), number, and size', 'timeFrame': 'At 2 weeks after intervention (EBL)', 'description': '1. presence of post ligation ulcer (Yes/NO)\n2. the number of ulcers if present.\n3. the maximum dimension of an ulcer (if present) in millimeter.'}, {'measure': 'Post endoscopic variceal ligation ulcers', 'timeFrame': 'At 2 weeks after intervention', 'description': 'Number of participants who experienced post-ligation ulcer.'}, {'measure': 'Post endoscopic variceal ligation bleeding', 'timeFrame': 'during the 2 weeks treatment duration', 'description': 'Number of participants who experienced post-ligation ulcer bleeding.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Vonoprazan-related adverse events as assessed by TRAEs grouped by Medical Dictionary for Regulatory Activities version 19.1', 'timeFrame': 'During the 2 weeks of medication use', 'description': '* The safety assessment will include all patients who will receive at least 1 dose of their assigned treatment.\n* 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:\n\n * Vital signs,\n * New onset hepatic encephalopathy,\n * New onset ascites OR Increasing a pre-existing ascites,\n * Changes in hemogram,\n * Liver aminotransferases,\n * Prothrombin time/INR\n * Serum Bilirubin\n * Serum urea and creatinine.\n\nThese data will be collected through:\n\n* Recording the baseline clinico-laboratory parameters at the 1st visit\n* Re-evaluation of the same parameters at 2 weeks follow-up visit\n* Encouraging the patients to communication with the study team in case of any other adverse events that may occur during the treatment duration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Portal Hypertension', 'Post-ligation ulcer', 'Vonoprazan', 'Pantoprazole', 'Variceal bleeding'], 'conditions': ['Portal Hypertension', 'Variceal Hemorrhage', 'Ulcer Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '26937932', 'type': 'BACKGROUND', 'citation': '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': '32088712', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSafety assessment:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Patients who completed the study protocol.\n* Eligible participants who are willing to comply with the study protocol and provide written consent.\n\nExclusion Criteria:\n\n* Endoscopically confirmed pre-existing esophageal ulcers\n* Ongoing therapy with any anti-acid agent,\n* Hepatocellular carcinoma\n* Portal vein thrombosis\n* Previous anti-flux procedure,\n* Barrett's esophagus,\n* History of liver transplantation,\n* Pregnancy, and allergy or past adverse reaction to acid-suppressive therapy\n* Estimated glomerular filtration rate \\< 60 mL/min/1.73 meter square."}, 'identificationModule': {'nctId': 'NCT05227833', 'briefTitle': 'Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Vonoprazan Vs. Pantoprazole in the Prevention of Post Endoscopic Band Ligation Ulcer/Bleeding in Portal Hypertensive Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0305413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vonoprazan', 'description': 'Vonoprazan (vonaspire 20 mg), tablets, one tablet per day before breakfast for 14 days starting from the day of band ligation.', 'interventionNames': ['Drug: Vonoprazan fumarate (Vonaspire)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pantoprazole', 'description': '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.', 'interventionNames': ['Drug: Pantoprazole 40mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'No acid suppressive medications will be described.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vonoprazan fumarate (Vonaspire)', 'type': 'DRUG', 'otherNames': ['Vonoprazan'], 'description': 'Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.', 'armGroupLabels': ['Vonoprazan']}, {'name': 'Pantoprazole 40mg', 'type': 'DRUG', 'otherNames': ['Pantoprazole Sodium'], 'description': '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.', 'armGroupLabels': ['Pantoprazole']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21521', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Alexandria Main University Hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Sameh Lashen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University Hospital, Alexandria, Alexandria Governorate, Egypt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sameh A. Lashen', 'investigatorAffiliation': 'Alexandria University'}}}}