Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-04 @ 9:10 AM
Study NCT ID:
NCT00303303
Status:
TERMINATED
Last Update Posted:
2023-12-01
First Post:
2006-03-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012909', 'term': 'Snake Bites'}], 'ancestors': [{'id': 'D001733', 'term': 'Bites and Stings'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069466', 'term': 'Red Meat'}, {'id': 'D008283', 'term': 'Maintenance'}, {'id': 'C431183', 'term': 'Crotalidae Polyvalent immune Fab'}], 'ancestors': [{'id': 'D008460', 'term': 'Meat'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkerns@carolinas.org', 'phone': '704-355-5297', 'title': 'William Kerns II MD Program Directorm Medical Toxicology', 'organization': 'Carolinas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Fab Antivenom followed by Fab antivenom maintenance', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Fab antivenom followed by placebo maintenance therapy', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'Placebo initial and maintenance therapy', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute hypersensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Limb Function: AMA Disability Rating Score of Envenomated Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '17.20', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '7.18', 'groupId': 'OG001'}, {'value': '22.67', 'spread': '24.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The range of possible scores is 0 - 100, and a lower score denotes less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Initial and Maintenance Therapy', 'description': 'Active Fab Antivenom initial therapy followed by active Fab antivenom maintenance therapy\n\nCrotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy): Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.'}, {'id': 'OG001', 'title': 'Fab Initial Therapy; Placebo Maintenance', 'description': 'Active initial Fab antivenom therapy followed by placebo maintenance therapy.\n\nCrotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy): Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.'}, {'id': 'OG002', 'title': 'Placebo Initial and Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy.\n\nPlacebo: Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '40.3', 'spread': '9.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Score ranges from 0-100 with higher scores meaning better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '55.78', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '55.18', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '54.09', 'spread': '3.96', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One year', 'description': 'Score ranges from 0-100 with higher scores meaning better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Limb Function: AAOS--time to Return to Normal Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '1.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Score ranges from 0-100 with higher scores meaning better function. Time in days to return to baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain: Visual Analog Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '18.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': '0-100 mm visual analog scale. Lower scores mean less pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'title': 'First 24 hours from baseline', 'categories': [{'measurements': [{'value': '5.2', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '40.5', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '15.6', 'groupId': 'OG002'}]}]}, {'title': 'First 6 hours from baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '15.95', 'spread': '9.32', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '2.45', 'groupId': 'OG002'}]}]}, {'title': 'first 18 hours from baseline', 'categories': [{'measurements': [{'value': '.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '13.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 6 hours from baseline, first 18 hours from baseline, First 24 hours from baseline, 12 months', 'description': 'Mg of morphine equivalents', 'unitOfMeasure': 'miligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected only for first 24 hours. Month 12 not collected.'}, {'type': 'SECONDARY', 'title': 'Swelling: Percentage (%) of Limb Spread Proximal From Bite Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Swelling: % Change in Volume Compared to Contralateral (Non-envenomated) Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '5', 'groupId': 'OG000'}, {'value': '2', 'spread': '6', 'groupId': 'OG001'}, {'value': '-8', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limb Function: Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '.25', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 4: data not collected from 3 participants in Fab Antivenom followed by Fab antivenom maintenance arm; data not collected from 3 participants in the Fab antivenom followed by placebo maintenance therapy arm; no data collected in the Placebo initial followed by placebo maintenance therapy arm. Data not collected at month 12 for any participants'}, {'type': 'SECONDARY', 'title': 'Limb Function: Physical or Occupational Therapy Sessions Attended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'unitOfMeasure': 'number of sessions', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 4: data not collected from 3 participants in Fab Antivenom followed by Fab antivenom maintenance arm; data not collected from 3 participants in the Fab antivenom followed by placebo maintenance therapy arm; data only collected from 1 in the Placebo initial followed by placebo maintenance therapy arm. Data not collected at month 12 for any participants'}, {'type': 'SECONDARY', 'title': 'Hematological: Clotting Studies and Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected at month 12'}, {'type': 'SECONDARY', 'title': 'Complications of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'OG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'OG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of participants with acute hypersensitivity reactions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fab Antivenom Followed by Fab Antivenom Maintenance', 'description': 'Fab Antivenom followed by Fab antivenom maintenance'}, {'id': 'FG001', 'title': 'Fab Antivenom Followed by Placebo Maintenance Therapy', 'description': 'Fab antivenom followed by placebo maintenance therapy'}, {'id': 'FG002', 'title': 'Placebo Initial Followed by Placebo Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Fab Initial and Maintenance Therapy', 'description': 'Active Fab Antivenom initial therapy followed by active Fab antivenom maintenance therapy'}, {'id': 'BG001', 'title': 'Experimental: Fab Initial Therapy; Placebo Maintenance', 'description': 'Active initial Fab antivenom therapy followed by placebo maintenance therapy.'}, {'id': 'BG002', 'title': 'Placebo Comparator: Placebo Initial and Maintenance Therapy', 'description': 'Placebo initial and maintenance therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '19.9', 'groupId': 'BG000'}, {'value': '41', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '39', 'spread': '19', 'groupId': 'BG002'}, {'value': '38.2', 'spread': '16.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Study terminated due to declining enrollment; data analysis proceeding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2006-03-14', 'resultsFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2006-03-14', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-06', 'studyFirstPostDateStruct': {'date': '2006-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limb Function: AMA Disability Rating Score of Envenomated Limb', 'timeFrame': '14 days', 'description': 'The range of possible scores is 0 - 100, and a lower score denotes less disability.'}, {'measure': 'Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb', 'timeFrame': '14 days', 'description': 'Score ranges from 0-100 with higher scores meaning better function.'}, {'measure': 'Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb', 'timeFrame': 'One year', 'description': 'Score ranges from 0-100 with higher scores meaning better function.'}, {'measure': 'Limb Function: AAOS--time to Return to Normal Value', 'timeFrame': '14 days', 'description': 'Score ranges from 0-100 with higher scores meaning better function. Time in days to return to baseline value.'}], 'secondaryOutcomes': [{'measure': 'Pain: Visual Analog Score', 'timeFrame': '14 days', 'description': '0-100 mm visual analog scale. Lower scores mean less pain.'}, {'measure': 'Pain Medication Use', 'timeFrame': 'First 6 hours from baseline, first 18 hours from baseline, First 24 hours from baseline, 12 months', 'description': 'Mg of morphine equivalents'}, {'measure': 'Swelling: Percentage (%) of Limb Spread Proximal From Bite Site', 'timeFrame': '12 months'}, {'measure': 'Swelling: % Change in Volume Compared to Contralateral (Non-envenomated) Limb', 'timeFrame': '14 days'}, {'measure': 'Limb Function: Return to Work', 'timeFrame': 'Week 4'}, {'measure': 'Limb Function: Physical or Occupational Therapy Sessions Attended', 'timeFrame': 'Week 4'}, {'measure': 'Hematological: Clotting Studies and Platelet Counts', 'timeFrame': '12 months'}, {'measure': 'Complications of Therapy', 'timeFrame': '12 months', 'description': 'Number of participants with acute hypersensitivity reactions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Snake envenomation', 'Antivenins', 'Disability evaluation', 'Activities of daily living'], 'conditions': ['Snake Envenomation']}, 'descriptionModule': {'briefSummary': 'Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite victims have long term problems with the function of the limb that was bitten. This study will determine whether early administration of antivenom to patients with mild to moderate copperhead snakebites reduces long-term complications.', 'detailedDescription': 'This study seeks to answer three important questions about the role of ovine (sheep-derived) antivenom in the treatment of people bitten by copperhead snakes (Agkistrodon contortrix):\n\n1. Although ovine antivenom has been approved by the FDA for treatment of copperhead envenomation, copperhead victims were excluded from the previous clinical trials. Animal experiments and retrospective human data suggest that the antivenom probably does work for copperhead snakebite, at least in the short term. This study will determine whether the antivenom is actually effective in reducing pain, swelling, and other immediate effects of copperhead snakebite.\n2. Deaths from copperhead snakebite are extremely rare, but survivors often report long term problems with pain and swelling in the envenomated limb. No study has formally measured the long-term outcomes in untreated snakebite, nor whether antivenom has any benefit in reducing the duration or severity of these complications. This study will answer this question through formal assessments of limb function up to 12 months after treatment.\n3. After initial control of the signs and symptoms of snakebite is achieved with antivenom therapy, some patients develop recurrent swelling or blood clotting problems. A randomized controlled trial in rattlesnake victims showed that the frequency of these problems is reduced by administration of 6 additional vials of antivenom over 18 hours ("maintenance therapy"). However, blood clotting problems are uncommon in copperhead snakebite even without antivenom treatment, and a retrospective trial suggested that maintenance therapy may have no effect on the frequency of delayed swelling in copperhead victims. In the typical copperhead victim, maintenance therapy increases the cost of treatment by more than 100%. This study will determine whether maintenance therapy is necessary in mild to moderate copperhead snakebite.\n\nPatients are eligible for enrollment if they have been bitten by a snake positively identified as a copperhead within 6 hours of enrollment, if they have signs of mild or moderate severity envenomation, and if contraindications are not present.\n\nAfter appropriate informed consent, patients are randomized to receive:\n\nA. initial stabilizing dose of antivenom, followed by maintenance therapy,\n\nB. initial stabilizing dose of antivenom followed by placebo in lieu of maintenance therapy, or\n\nC. placebo for both initial dose and maintenance.\n\nAll laboratory testing, pain medication, hospitalization, and other therapies are standard for snakebite of this severity. If at any time the envenomation becomes severe, antivenom is administered.\n\nIn addition to the standard assessments performed on all snakebite victims (swelling, pain, vital signs, blood clotting, complications of therapy), patients in this study receive formal assessments of the function of the envenomated limb. This assessment uses the AMA disability rating system and the American Academy of Orthopedic Surgeons\' Normative Outcomes Study questionnaire do determine how well the limbs function and how well the limbs perform and how much any remaining problems interfere with the patients\' long-term happiness and ability to perform common activities of daily living.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Envenomation by copperhead snake (Agkistrodon contortrix) within 6 hours\n* Mild or moderate severity envenomation\n\nExclusion Criteria:\n\n* Allergy to antivenom or components\n* Severe envenomation (hypotension, severe swelling, compartment syndrome, bleeding, etc.)\n* Uncertain snake ID\n* Prior treatment with antivenom'}, 'identificationModule': {'nctId': 'NCT00303303', 'briefTitle': 'The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations', 'orgStudyIdInfo': {'id': '06-01-12B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fab initial and maintenance therapy', 'description': 'Active Fab Antivenom initial therapy followed by active Fab antivenom maintenance therapy', 'interventionNames': ['Biological: Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)']}, {'type': 'EXPERIMENTAL', 'label': 'Fab initial therapy; placebo maintenance', 'description': 'Active initial Fab antivenom therapy followed by placebo maintenance therapy.', 'interventionNames': ['Biological: Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo initial and maintenance therapy', 'description': 'Placebo initial and maintenance therapy.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)', 'type': 'BIOLOGICAL', 'otherNames': ['CroFab (tm)'], 'description': 'Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.', 'armGroupLabels': ['Fab initial and maintenance therapy']}, {'name': 'Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)', 'type': 'BIOLOGICAL', 'otherNames': ['CroFab (tm)'], 'description': 'Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.', 'armGroupLabels': ['Fab initial therapy; placebo maintenance']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.', 'armGroupLabels': ['Placebo initial and maintenance therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28232', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Richland Memorial Hospital', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medical College of Virigina/Virginia Commonwealth University Hospital', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'William P Kerns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolinas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}