|Marie Stuart, M.D.|
2 United States sites
10 to 19 Years
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 or HbSβo Thal.
– History of ≥3 vasocclusive pain events in preceding 12 months.
– Regular compliance with comprehensive care.
– Aged 10 years or greater and less than 20 years.
– At enrollment, subject should be in his/her steady or baseline state.
– Subjects with Hb levels <5.5gm/dL.
- Inability to take or tolerate oral medications.
- Poor compliance with previous treatment regimens.
- Hepatic dysfunction (SGPT also known as ALT >2X upper limit of normal or conjugated
bilirubin >2X the patients baseline within the last 6 weeks).
– Renal dysfunction (A creatinine level within the past 6 weeks of ≥ 1.0mg/dL for
children and ≥ 1.2mg/dL for a subject ≥ 18 years of age).
– Allergy to fish or shell fish.
– Triglyceride levels <80mg/dL.
- Chronic Transfusion Therapy.
- Transfusion within the last 30 days.
- Persistent pain from sickle-complications (e.g. avascular necrosis).
- A vasocclusive pain episode lasting longer than 2 weeks or >12 pain episodes in
– Daily narcotic usage.
– Treatment with any investigational drug or regular fish oil supplementations in last
– Currently receiving another investigational agent, or on such an agent with the last
– Dosage changes in preceding 3 months if on hydroxyurea.
– Bleeding disorder or patient on concomitant anti-coagulation.
– Conditional or abnormal TCD result or stroke.
– Other chronic illness that could adversely affect subjects performance such as HIV or
– Children in Care (CiC): A child in care is a child who has been placed under the
control or protection of an agency, organization, institution or entity by the courts,
the government or a government body, acting in accordance with powers conferred on
them by law or regulation.