Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT02947100
Eligibility Criteria:
Inclusion Criteria:
Subjects who meet all of the following criteria are eligible for enrollment into the study:
* Participant has signed the informed consent/assent with parent signing informed consent as age appropriate.
* Established diagnosis of HbSS, HbSC or HbSβo Thalassemia
* History of ≥1 vasoocclusive events (managed at home and/or in hospital) in preceding 12 months.
* Regular compliance with comprehensive care.
* Aged 8 years or greater and less than 26 years.
* 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
Exclusion Criteria:
* Baseline hemoglobin levels \<5.5 gm/dL.
* Inability to swallow capsules
* Poor compliance with previous treatment regimens.
* Hepatic dysfunction
* Renal dysfunction
* PT and/or PTT ≥ 20% outside of normal
* Allergy to fish, shell fish or soy
* Triglyceride levels \<80mg/dL.
* Pregnancy.
* Chronic Transfusion Therapy.
* Transfusion within the last 30 days.
* Treatment with any investigational drug or regular fish oil supplementations in last 60 days.
* Currently receiving another investigational agent, or on such an agent with the last 60 days.
* Dosage changes in preceding 3 months if on hydroxyurea
* Diagnosed bleeding disorder or patient on concomitant anti-coagulation.
* Conditional or abnormal result on most recent transcranial doppler or history of stroke.
* Other active chronic illness that could adversely affect subjects performance
* Children in Care
* Platelet count less than 100,000
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
25 Years
Study:
NCT02947100
Study Brief:
Protocol Section:
NCT02947100