Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT00630656
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
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': 'C515276', 'term': 'talactoferrin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'dispFirstSubmitDate': '2011-08-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-18', 'studyFirstSubmitDate': '2008-02-28', 'dispFirstSubmitQcDate': '2011-08-11', 'studyFirstSubmitQcDate': '2008-02-28', 'dispFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '28-day'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '3 months'}, {'measure': 'All-cause mortality', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'talactoferrin', 'lactoferrin', 'recombinant human lactoferrin'], 'conditions': ['Severe Sepsis']}, 'referencesModule': {'references': [{'pmid': '23425819', 'type': 'DERIVED', 'citation': 'Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.'}]}, 'descriptionModule': {'briefSummary': 'Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Onset of severe sepsis within the previous 24 hours\n* Must be receiving antibiotic therapy\n* Informed consent form signed by patient, legal next-of-kin or legal guardian\n* Able to take medication by mouth or feeding tube\n\nExclusion Criteria:\n\n* Receipt of investigational medication within 4 weeks prior to participation in the study\n* Pregnant or breast-feeding\n* Severe congestive heart failure\n* Known severe HIV infection\n* Presence of severe burns\n* Patients on high dose immunosuppressants\n* Patients whose death is considered imminent\n* Patients whose life expectancy for concurrent illness is less than 6 months\n* Severe hypoxic encephalopathy or persistent vegetative state\n* Severe liver disease\n* Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support"}, 'identificationModule': {'nctId': 'NCT00630656', 'briefTitle': 'Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agennix'}, 'officialTitle': 'A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': 'LF-0801'}, 'secondaryIdInfos': [{'id': 'NIH grant 1R44GM077816-01A2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Talactoferrin alfa', 'interventionNames': ['Drug: Talactoferrin alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Talactoferrin alfa', 'type': 'DRUG', 'description': '15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View- UCLA Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60302', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'West Suburban Medical Center', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '47105', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Floyd Memorial Hospital and Health Services', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinic', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27517', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ben Taub General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Memorial Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': '82013', 'city': 'Montauban', 'country': 'France', 'facility': 'Centre Hospitalier de Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '16470', 'city': 'Saint-Michel', 'country': 'France', 'facility': 'Centre Hospitalier Angouleme', 'geoPoint': {'lat': 49.91952, 'lon': 4.13278}}, {'zip': '99089', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Helios Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Kalpalatha K Guntupalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agennix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}