Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-29 @ 9:09 AM
Study NCT ID:
NCT04845659
Status:
UNKNOWN
Last Update Posted:
2021-04-15
First Post:
2021-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avatrombopaq In Patients With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533238', 'term': 'avatrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-11', 'studyFirstSubmitDate': '2021-04-11', 'studyFirstSubmitQcDate': '2021-04-11', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '3 months postprocedural', 'description': 'Mortality, bleedning, blood clots, readmission, reoperation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cirrhosis', 'Thrombocytopenia'], 'conditions': ['Thrombocytopenia; Drugs', 'Cirrhosis, Liver', 'Procedural Bleeding']}, 'descriptionModule': {'briefSummary': 'Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia \\< 50\\*10\\^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\\< 50\\*10\\^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (\\< 50\\*10\\^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\>17 years and ≤80 years\n* ASA I-III\n* Patients who read, understood and signed informed consent.\n* Patients with a diagnosis of cirrhosis\n* Thrombocytopenia \\<50\\*109\n* The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.\n\nExclusion Criteria:\n\n* Patients who do not speak and understand Danish.\n* Patients who cannot cooperate within the trial.\n* Patients who did not sign an informed consent regardless of the cause.\n* Active drug abuse - to the discretion of the investigator.\n* Thrombocytes \\>50\\*10\\^9\n* Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation).\n* INR \\> 1,7\n* Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)'}, 'identificationModule': {'nctId': 'NCT04845659', 'acronym': 'AIPAC', 'briefTitle': 'Avatrombopaq In Patients With Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Treatment With Avatrombopaq in Patients With Cirrhosis Undergoing Small Invasive Procedure: A Prospective Case Series', 'orgStudyIdInfo': {'id': 'AIPAC21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Avatrombopaq administration', 'interventionNames': ['Drug: Doptelet Pill']}], 'interventions': [{'name': 'Doptelet Pill', 'type': 'DRUG', 'description': '40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christian Snitkjær, M.B.', 'role': 'CONTACT', 'email': 'christian_snit@hotmail.com', 'phone': '+4523670279'}, {'name': 'Line Molzen, M.D.', 'role': 'CONTACT', 'email': 'line.molzen.02@regionh.dk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.B.', 'investigatorFullName': 'Christian Snitkjær', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}