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

Primary Purpose

Sickle Cell Disease, HEMOGLOBIN SS, Hemoglobin S Beta-0 Thalassemia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)

Placebo Capsules

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Anemia, Sickle Cell Disease, Hemoglobin SS Disease, Hemoglobin S beta-0 Thalassemia, Inflammation, Quality of Life, Sickle Thalassemia, C-Reative Protein, Hemolytic Anemia, Hemostasis, Biomarkers, Coagulation, Omega-3 Fatty Acids, Eicosapentaenoic Acid, Docosahexaenoic Acid, Fish Oils, Drug: Placebo, Drug: LOVAZA

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Thomas Jefferson University Hospital
St. Christopher's Hospital for Children, Drexel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LOVAZA

Placebo capsule

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01202812

First Posted

September 14, 2010

Last Updated

October 22, 2010

Sponsor

Thomas Jefferson University

Collaborators

Drexel University, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01202812

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Thomas Jefferson University

Collaborators

Drexel University, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Sickle Cell Anemia, Sickle Cell Disease, Hemoglobin SS Disease, Hemoglobin S beta-0 Thalassemia, Inflammation, Quality of Life, Sickle Thalassemia, C-Reative Protein, Hemolytic Anemia, Hemostasis, Biomarkers, Coagulation, Omega-3 Fatty Acids, Eicosapentaenoic Acid, Docosahexaenoic Acid, Fish Oils, Drug: Placebo, Drug: LOVAZA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LOVAZA

Arm Type

Experimental

Arm Title

Placebo capsule

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)

Other Intervention Name(s)

- Fish Oils, - Eicosapentaenoic Acid, - Docosahexaenoic Acid, - Omega-3 Fatty Acid

Intervention Description

Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.

Intervention Type

Other

Intervention Name(s)

Placebo Capsules

Other Intervention Name(s)

- Placebo

Intervention Description

Placebo capsules given by mouth daily for 6 months.

Primary Outcome Measure Information:

Title

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Stuart, M.D.

Phone

215-955-1819 cell-215.847.1471

marie.stuart@jefferson.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Stuart, M.D.

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie Stuart, M.D.

First Name & Middle Initial & Last Name & Degree

Suba Krishnan, M.D.

First Name & Middle Initial & Last Name & Degree

B.N. Yamaja Setty, Ph.D.

Facility Name

St. Christopher's Hospital for Children, Drexel University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134-1095

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norma Lerner, M.D.

Phone

215-427-5261

norma.lerner@tenethealth.com

First Name & Middle Initial & Last Name & Degree

Maureen Meier, RN, CCRC

Phone

215-427-3835

maureen.meier@tenethealth.com

First Name & Middle Initial & Last Name & Degree

Maureen Meier, RN, CCRC

12. IPD Sharing Statement

Citations:

PubMed Identifier

11434703

Citation

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.

Results Reference

background

PubMed Identifier

19995398

Citation

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.

Results Reference

background

PubMed Identifier

20658620

Citation

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.

Results Reference

background

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

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