Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-28 @ 2:11 PM
Study NCT ID:
NCT02947100
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omega-3 Fatty Acids in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rmiller@nemours.org', 'phone': '302-651-5500', 'title': 'Dr Robin Miller', 'organization': 'Nemours/AI duPont Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Until one month after stopping study drug', 'eventGroups': [{'id': 'EG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'fever', 'notes': 'influenza B, unlikely related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'notes': 'stomach cramping and constipation. Unlikely related to study medication as this was a preexisting problem.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vasoocclusive crisis', 'notes': 'painful vasoocclusive crisis related to sickle cell disease, unlikely related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'transient nausea, unlikely related to study medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stye', 'notes': 'stye left lower eyelid, unlikely related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'eczematous rash, unlikely related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nosebleed', 'notes': 'self limited, less than 5 minutes, unlikely related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': "Mondor's disease", 'notes': "Subject developed Mondor's disease one month after study drug was stopped due to study suspension. Admitted to hospital for one night of observation, resolved without treatment. The SAE was deemed unrelated to study medication.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Safety, in a Dose Escalation Trial of SCD-Omegatex™ as Evidenced by an Absence of Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'timeFrame': '6 months with continuous monitoring', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug'}, {'type': 'PRIMARY', 'title': 'Determine Whether 6 Months of Supplementation With SCD-Omegatex™ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug'}, {'type': 'SECONDARY', 'title': 'Health-associated Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug'}, {'type': 'SECONDARY', 'title': 'Number of Days With Pain Measured by iPad Daily Report Pain Calendar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'timeFrame': '8 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug'}, {'type': 'SECONDARY', 'title': 'Changes in Individual Thermal Sensitivity Thresholds by QST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'timeFrame': '8 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Thrombin Generation as Assessed by Calibrated Automated Thrombogram', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'High Sensitivity C-reactive Protein (mg/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Lipidomic Analysis', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Urine Resolvin D1 (pg/mg Creatinine)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Levels of Lactate Dehydrogenase (IU/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fetal Hemoglobin (%)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Analysis of Pro and Anti-inflammatory Cytokines in Plasma Including Interleukin (IL)1-beta, IL-4, IL-6, IL-8, IL-10 and Tumor Necrosis Factor (TNF) Alpha ( pg/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Endothelin-1(pg/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Levels Soluble Vascular Adhesion Molecule -1 (VCAM-1) (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Levels of Soluble P-selectin (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Levels of Soluble L-selectin (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemostatic Markers in Plasma Including D-dimers and Prothrombin Fragment 1.2 (Nmol/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'study terminated early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SCD-Omegatex™', 'description': 'single arm\n\nSCD-Omegatex™: Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-18', 'size': 2333937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-22T17:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'manufacturing problem with study drug', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2016-10-18', 'resultsFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-22', 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thrombin Generation as Assessed by Calibrated Automated Thrombogram', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'High Sensitivity C-reactive Protein (mg/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Lipidomic Analysis', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Urine Resolvin D1 (pg/mg Creatinine)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Levels of Lactate Dehydrogenase (IU/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Fetal Hemoglobin (%)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Analysis of Pro and Anti-inflammatory Cytokines in Plasma Including Interleukin (IL)1-beta, IL-4, IL-6, IL-8, IL-10 and Tumor Necrosis Factor (TNF) Alpha ( pg/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Endothelin-1(pg/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Levels Soluble Vascular Adhesion Molecule -1 (VCAM-1) (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Levels of Soluble P-selectin (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Plasma Levels of Soluble L-selectin (ng/ml)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Hemostatic Markers in Plasma Including D-dimers and Prothrombin Fragment 1.2 (Nmol/L)', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}], 'primaryOutcomes': [{'measure': 'Clinical Safety, in a Dose Escalation Trial of SCD-Omegatex™ as Evidenced by an Absence of Adverse Events.', 'timeFrame': '6 months with continuous monitoring', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Determine Whether 6 Months of Supplementation With SCD-Omegatex™ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}], 'secondaryOutcomes': [{'measure': 'Health-associated Quality of Life', 'timeFrame': '6 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Number of Days With Pain Measured by iPad Daily Report Pain Calendar', 'timeFrame': '8 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}, {'measure': 'Changes in Individual Thermal Sensitivity Thresholds by QST', 'timeFrame': '8 months', 'description': 'No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'omega-3 fatty acids', 'Docosahexaenoic Acid (DHA)', 'Eicosapentaenoic Acid (EPA)'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '23193009', 'type': 'BACKGROUND', 'citation': 'Daak AA, Ghebremeskel K, Hassan Z, Attallah B, Azan HH, Elbashir MI, Crawford M. Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2013 Jan;97(1):37-44. doi: 10.3945/ajcn.112.036319. Epub 2012 Nov 28.'}, {'pmid': '17090225', 'type': 'BACKGROUND', 'citation': 'Serhan CN. Resolution phase of inflammation: novel endogenous anti-inflammatory and proresolving lipid mediators and pathways. Annu Rev Immunol. 2007;25:101-37. doi: 10.1146/annurev.immunol.25.022106.141647.'}, {'pmid': '25149823', 'type': 'BACKGROUND', 'citation': 'Calder PC. Marine omega-3 fatty acids and inflammatory processes: Effects, mechanisms and clinical relevance. Biochim Biophys Acta. 2015 Apr;1851(4):469-84. doi: 10.1016/j.bbalip.2014.08.010. Epub 2014 Aug 20.'}, {'pmid': '11434703', 'type': 'BACKGROUND', 'citation': 'Tomer A, Kasey S, Connor WE, Clark S, Harker LA, Eckman JR. Reduction of pain episodes and prothrombotic activity in sickle cell disease by dietary n-3 fatty acids. Thromb Haemost. 2001 Jun;85(6):966-74.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of a new formulation of the omega-3 fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether it decreases inflammation and inflammatory pain in children and young adults with Sickle Cell Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects who meet all of the following criteria are eligible for enrollment into the study:\n\n* Participant has signed the informed consent/assent with parent signing informed consent as age appropriate.\n* Established diagnosis of HbSS, HbSC or HbSβo Thalassemia\n* History of ≥1 vasoocclusive events (managed at home and/or in hospital) in preceding 12 months.\n* Regular compliance with comprehensive care.\n* Aged 8 years or greater and less than 26 years.\n* At enrollment, subject should be in his/her baseline steady state and not in the midst of any acute complication due to SCD. Must be at least 2 weeks from infection or vasoocclusive crisis at time of screening labs\n\nExclusion Criteria:\n\n* Baseline hemoglobin levels \\<5.5 gm/dL.\n* Inability to swallow capsules\n* Poor compliance with previous treatment regimens.\n* Hepatic dysfunction\n* Renal dysfunction\n* PT and/or PTT ≥ 20% outside of normal\n* Allergy to fish, shell fish or soy\n* Triglyceride levels \\<80mg/dL.\n* Pregnancy.\n* Chronic Transfusion Therapy.\n* Transfusion within the last 30 days.\n* Treatment with any investigational drug or regular fish oil supplementations in last 60 days.\n* Currently receiving another investigational agent, or on such an agent with the last 60 days.\n* Dosage changes in preceding 3 months if on hydroxyurea\n* Diagnosed bleeding disorder or patient on concomitant anti-coagulation.\n* Conditional or abnormal result on most recent transcranial doppler or history of stroke.\n* Other active chronic illness that could adversely affect subjects performance\n* Children in Care\n* Platelet count less than 100,000'}, 'identificationModule': {'nctId': 'NCT02947100', 'briefTitle': 'Omega-3 Fatty Acids in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Phase I/II Safety and Dose Escalation Trial of the Omega-3 Fatty Acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) in Children and Young Adults With Sickle Cell Disease (SCD)', 'orgStudyIdInfo': {'id': 'RM002'}, 'secondaryIdInfos': [{'id': 'P20GM109021', 'link': 'https://reporter.nih.gov/quickSearch/P20GM109021', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCD-Omegatex™', 'description': 'single arm', 'interventionNames': ['Drug: SCD-Omegatex™']}], 'interventions': [{'name': 'SCD-Omegatex™', 'type': 'DRUG', 'otherNames': ['Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule'], 'description': 'Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.', 'armGroupLabels': ['SCD-Omegatex™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours/Alfred I duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}], 'overallOfficials': [{'name': 'Robin E Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Clinic"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robin E. Miller', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, {'name': 'Solutex GC S.L.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Robin E. Miller', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}