Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00021502
Status:
COMPLETED
Last Update Posted:
2009-08-14
First Post:
2001-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C050907', 'term': 'pyridoxalated-hemoglobin-polyethylene glycol conjugate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-13', 'studyFirstSubmitDate': '2001-07-18', 'studyFirstSubmitQcDate': '2001-07-19', 'lastUpdatePostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)', 'Systemic Inflammatory Response Syndrome (SIRS)', 'Nitric oxide (NO)', 'Shock'], 'conditions': ['Shock', 'Systemic Inflammatory Response Syndrome']}, 'referencesModule': {'references': [{'pmid': '18552688', 'type': 'RESULT', 'citation': 'Kinasewitz GT, Privalle CT, Imm A, Steingrub JS, Malcynski JT, Balk RA, DeAngelo J. Multicenter, randomized, placebo-controlled study of the nitric oxide scavenger pyridoxalated hemoglobin polyoxyethylene in distributive shock. Crit Care Med. 2008 Jul;36(7):1999-2007. doi: 10.1097/CCM.0b013e31817bfe84.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.', 'detailedDescription': 'This Phase 3, randomized, placebo controlled, multi-center study is designed to evaluate the safety and efficacy of continuous IV infusion of PHP plus conventional vasopressor treatment, as compared to continuous IV infusion of Plasma-Lyte A plus conventional vasopressor, as a treatment for restoring hemodynamic stability in SIRS patients with shock. Conventional vasopressors include dopamine \\> 5 mcg/kg/min; or norepinephrine, phenylephrine or epinephrine at any dose.\n\nThe study consists of a Screening period, a Pre-Treatment period, and a 28-day Treatment period. Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period.\n\nThe safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of:\n\n* all cause mortality,\n* median patient survival time and\n* adverse event rates and duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Determination of study eligibility will be made by the Investigator on the basis of the inclusion criteria listed below:\n\nSIRS Inclusion Criteria\n\nPatients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):\n\n* Either respiratory rate \\>/= 20 breaths/minute, partial pressure of arterial carbon dioxide (PaCO2) \\</= 32 torr, or mechanical ventilation,\n* Heart rate \\>/= 90 beats/minute,\n* Either hyperthermia \\>/= 38 degrees C, or hypothermia \\</= 36 degrees C or\n* Either white blood cell (WBC) \\>/= 12,000 cells/mm3, \\</= 4,000 cells/mm3, or \\>/= 10% immature (band) forms\n\nShock Inclusion Criteria Patients with adequate fluid resuscitation (PCWP \\>/= 12mmHg) and with one or more conventional vasopressors (continuing up to the time of randomization) being used to treat hypotension (MBP \\< 60 mmHg or SBP \\< 90 mmHg). Patients cannot be entered if they have been in shock for more than 24 hours.'}, 'identificationModule': {'nctId': 'NCT00021502', 'briefTitle': 'Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apex Bioscience'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Placebo Controlled Study of PHP When Administered by Continuous Infusion in Patients With Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)', 'orgStudyIdInfo': {'id': 'APX-PHP 99-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apex Bioscience', 'class': 'INDUSTRY'}}}}