Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:15 PM
Study NCT ID:
NCT03245528
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2018-03-08
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access for LJPC-501
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000803', 'term': 'Angiotensin I'}], 'ancestors': [{'id': 'D000809', 'term': 'Angiotensins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2018-03', 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Catecholamine Resistant Hypotension (CRH)', 'Distributive Shock', 'High Output Shock', 'Sepsis', 'Vasodilatory Shock']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.', 'detailedDescription': 'Primary Objective\n\nThe primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.\n\nSecondary Objective\n\nThe secondary objective of the study is to assess the safety of LJPC-501.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of \\> 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.\n* Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.\n* Patients must be adequately volume resuscitated in the opinion of the treating investigator.\n* Patients must have clinical features of distributive shock documented by either estimated or measured CI \\> 2.3 L/min/m\\^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP \\> 8 mmHg and ScvO2 \\> 70%.\n* Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.\n\nExclusion Criteria:\n\n* Patients with a MAP \\> 80 mmHg.\n* Patients diagnosed with acute occlusive coronary syndrome requiring intervention.\n* Patients who have been on ECMO \\< 6 hours.\n* Patients in liver failure with a MELD score ≥ 30.\n* Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.\n* Patients with acute mesenteric ischemic or history of mesenteric ischemia.\n* Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.\n* Patients with an expected lifespan of \\< 24 hours.\n* Patients with active bleeding AND an anticipated need for transfusion of \\> 4 units PRBCs within 48 hours of the initiation of LJPC-501.\n* Patients with active bleeding AND hemoglobin \\< 7 g/dL.\n* Patients with an ANC \\< 500 cells/mm\\^3.\n* Patients with a known allergy to mannitol.\n* Patients who are currently participating in an investigational interventional trial.\n* Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential."}, 'identificationModule': {'nctId': 'NCT03245528', 'briefTitle': 'Expanded Access for LJPC-501', 'organization': {'class': 'INDUSTRY', 'fullName': 'La Jolla Pharmaceutical Company'}, 'officialTitle': 'Expanded Access for LJPC-501', 'orgStudyIdInfo': {'id': 'LJ501-EAP01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LJPC-501', 'type': 'DRUG', 'description': 'angiotensin II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'La Jolla Pharmaceutical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}