A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - 19 |
| Updated: | 4/2/2016 |
| Start Date: | October 2010 |
| End Date: | March 2012 |
| Contact: | Marie Stuart, M.D. |
| Email: | marie.stuart@jefferson.edu |
| Phone: | 215-955-1819 cell-215.847.1471 |
Phase II Randomized Double-Blind Placebo-Controlled Trial of the Omega-3 Fatty Acids Eicosapentaenoic (EPA) and Docosahexaenoic Acid (DHA) in Pediatric Sickle Cell Disease (SCD)
The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to
decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has
been found that besides the damage caused by sickle red blood cells themselves, the
inflammatory response that occurs in SCD patients could potentially play a significant role
in the occurrence of painful episodes or pain crises. The investigators will also study
whether the subject/caregiver feels that there is an improvement in the child's quality of
life by taking the medication. Besides the effect of LOVAZA on inflammation,the
investigators are also testing whether the drug will have a beneficial effect on blood
clotting ability (which is known to be increased in SCD) and on the anemia (low red blood
cells) that is part of the disease entity.
decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has
been found that besides the damage caused by sickle red blood cells themselves, the
inflammatory response that occurs in SCD patients could potentially play a significant role
in the occurrence of painful episodes or pain crises. The investigators will also study
whether the subject/caregiver feels that there is an improvement in the child's quality of
life by taking the medication. Besides the effect of LOVAZA on inflammation,the
investigators are also testing whether the drug will have a beneficial effect on blood
clotting ability (which is known to be increased in SCD) and on the anemia (low red blood
cells) that is part of the disease entity.
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.
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