Status:
UNKNOWN
A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Drexel University
GlaxoSmithKline
Conditions:
Sickle Cell Disease
HEMOGLOBIN SS
Eligibility:
All Genders
10-19 years
Phase:
PHASE2
Brief Summary
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 bes...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01202812
Start Date
October 1 2010
End Date
March 1 2012
Last Update
October 25 2010
Active Locations (2)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
2
St. Christopher's Hospital for Children, Drexel University
Philadelphia, Pennsylvania, United States, 19134-1095