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

• ClinicalTrials.gov Identifier: NCT01202812
• Recruitment Status: Unknown
• First Posted: September 16, 2010
• Last Update Posted: October 25, 2010
• Sponsor: Thomas Jefferson University
• Collaborators: Drexel University; GlaxoSmithKline
• Information provided by: Thomas Jefferson University

Tracking Information

• First Submitted Date: September 14, 2010
• First Posted Date: September 16, 2010
• Last Update Posted Date: October 25, 2010
• Study Start Date: October 2010
• Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 15, 2010): To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD). [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 15, 2010): To determine whether supplementation with LOVAZA will increase health-associated quality of life (QoL) responses as they relate to clinical vasocclusive events (VOC) in children and adolescents with Sickle Cell Disease (SCD). [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
• Official Title: 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)
• 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• HEMOGLOBIN SS
• Hemoglobin S Beta-0 Thalassemia
• Inflammation
• Quality of Life

Intervention

• Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
  Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.
  Other Names:

  • - Fish Oils
  • - Eicosapentaenoic Acid
  • - Docosahexaenoic Acid
  • - Omega-3 Fatty Acid
• Other: Placebo Capsules
  Placebo capsules given by mouth daily for 6 months.
  Other Name: - Placebo

Study Arms

• Experimental: LOVAZA
  Intervention: Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
• Placebo Comparator: Placebo capsule
  Intervention: Other: Placebo Capsules

Publications *

• Tomer A, Kasey S, Connor WE, Clark S, Harker LA, Eckman JR. Reduction of pain episodes and prothrombotic activity in sickle cell disease by dietary n-3 fatty acids. Thromb Haemost. 2001 Jun;85(6):966-74.
• Krishnan S, Setty Y, Betal SG, Vijender V, Rao K, Dampier C, Stuart M. Increased levels of the inflammatory biomarker C-reactive protein at baseline are associated with childhood sickle cell vasocclusive crises. Br J Haematol. 2010 Mar;148(5):797-804. doi: 10.1111/j.1365-2141.2009.08013.x. Epub 2009 Dec 8.
• Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W; Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC). Health-related quality of life in children with sickle cell disease: a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer. 2010 Sep;55(3):485-94. doi: 10.1002/pbc.22497.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 15, 2010): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2012
• Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01202812
• Other Study ID Numbers: 10F.161
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Marie Stuart, MD, Thomas Jefferson University
• Original Responsible Party: Same as current
• Current Study Sponsor: Thomas Jefferson University
• Original Study Sponsor: Same as current

Collaborators

• Drexel University
• GlaxoSmithKline

Investigators

• Principal Investigator: Marie Stuart, M.D.; Thomas Jefferson University

• PRS Account: Thomas Jefferson University
• Verification Date: October 2010