A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)

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 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.

Exclusion Criteria

• 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.
• Pregnancy.
• 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 preceding year.
• Daily narcotic usage.
• 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.
• 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 TB.
• 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.