Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P20GM109021 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
manufacturing problem with study drug
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| Thomas Jefferson University | OTHER |
| Solutex GC S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCD-Omegatexâ„¢ | Experimental | single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD-Omegatexâ„¢ | Drug | Subjects will receive SCD-Omegatexâ„¢ (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Safety, in a Dose Escalation Trial of SCD-Omegatexâ„¢ as Evidenced by an Absence of Adverse Events. | 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. | 6 months with continuous monitoring |
| Determine Whether 6 Months of Supplementation With SCD-Omegatexâ„¢ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-associated Quality of Life | 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. | 6 months |
| Number of Days With Pain Measured by iPad Daily Report Pain Calendar |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin Generation as Assessed by Calibrated Automated Thrombogram | 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. | 6 months |
| High Sensitivity C-reactive Protein (mg/L) |
Inclusion Criteria:
Subjects who meet all of the following criteria are eligible for enrollment into the study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robin E Miller, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/Alfred I duPont Hospital for Children | Wilmington | Delaware | 19899 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23193009 | Background | 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. | |
| 17090225 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SCD-Omegatexâ„¢ | single arm SCD-Omegatexâ„¢: Subjects will receive SCD-Omegatexâ„¢ (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SCD-Omegatexâ„¢ | single arm SCD-Omegatexâ„¢: Subjects will receive SCD-Omegatexâ„¢ (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Safety, in a Dose Escalation Trial of SCD-Omegatexâ„¢ as Evidenced by an Absence of Adverse Events. | 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. | Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug | Posted | 6 months with continuous monitoring |
|
Until one month after stopping study drug
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCD-Omegatexâ„¢ | single arm SCD-Omegatexâ„¢: Subjects will receive SCD-Omegatexâ„¢ (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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mondor's disease | Reproductive system and breast disorders | Systematic Assessment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | General disorders | Systematic Assessment | influenza B, unlikely related to study medication |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robin Miller | Nemours/AI duPont Hospital | 302-651-5500 | rmiller@nemours.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2018 | Sep 22, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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. |
| 8 months |
| Changes in Individual Thermal Sensitivity Thresholds by QST | 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. | 8 months |
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. |
| 6 months |
| Plasma Lipidomic Analysis | 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. | 6 months |
| Urine Resolvin D1 (pg/mg Creatinine) | 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. | 6 months |
| Plasma Levels of Lactate Dehydrogenase (IU/L) | 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. | 6 months |
| Fetal Hemoglobin (%) | 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. | 6 months |
| 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) | 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. | 6 months |
| Plasma Endothelin-1(pg/ml) | 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. | 6 months |
| Plasma Levels Soluble Vascular Adhesion Molecule -1 (VCAM-1) (ng/ml) | 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. | 6 months |
| Plasma Levels of Soluble P-selectin (ng/ml) | 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. | 6 months |
| Plasma Levels of Soluble L-selectin (ng/ml) | 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. | 6 months |
| Hemostatic Markers in Plasma Including D-dimers and Prothrombin Fragment 1.2 (Nmol/L) | 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. | 6 months |
| 25149823 | Background | 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. |
| 11434703 | Background | 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. |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Determine Whether 6 Months of Supplementation With SCD-Omegatexâ„¢ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels | 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. | Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug | Posted | 6 months |
|
|
| Secondary | Health-associated Quality of Life | 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. | Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug | Posted | 6 months |
|
|
| Secondary | Number of Days With Pain Measured by iPad Daily Report Pain Calendar | 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. | Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug | Posted | 8 months |
|
|
| Secondary | Changes in Individual Thermal Sensitivity Thresholds by QST | 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. | Study was stopped early, before outcomes could be measured, due to manufacturing issues with the study drug | Posted | 8 months |
|
|
| Other Pre-specified | Thrombin Generation as Assessed by Calibrated Automated Thrombogram | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | High Sensitivity C-reactive Protein (mg/L) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Lipidomic Analysis | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Urine Resolvin D1 (pg/mg Creatinine) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Levels of Lactate Dehydrogenase (IU/L) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Fetal Hemoglobin (%) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Endothelin-1(pg/ml) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Levels Soluble Vascular Adhesion Molecule -1 (VCAM-1) (ng/ml) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Levels of Soluble P-selectin (ng/ml) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Plasma Levels of Soluble L-selectin (ng/ml) | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Hemostatic Markers in Plasma Including D-dimers and Prothrombin Fragment 1.2 (Nmol/L) | 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. | Not Posted | 6 months | Participants |
| 0 |
| 3 |
| 1 |
| 3 |
| 1 |
| 4 |
|
|
| constipation | Gastrointestinal disorders | Systematic Assessment | stomach cramping and constipation. Unlikely related to study medication as this was a preexisting problem. |
|
| vasoocclusive crisis | Musculoskeletal and connective tissue disorders | Systematic Assessment | painful vasoocclusive crisis related to sickle cell disease, unlikely related to study medication |
|
| nausea | Gastrointestinal disorders | Systematic Assessment | transient nausea, unlikely related to study medication. |
|
| stye | Eye disorders | Systematic Assessment | stye left lower eyelid, unlikely related to study medication |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | eczematous rash, unlikely related to study drug |
|
| nosebleed | Blood and lymphatic system disorders | Systematic Assessment | self limited, less than 5 minutes, unlikely related to study medication |
|
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |