IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

Sponsor

Anthera Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00434473

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease Vaso-occlusive Crisis Acute Chest Syndrome	Drug: A-001 Other: Placebo	Phase 2

Detailed Description

This is a double-blind randomized, parallel group, placebo-controlled dose escalation study (2 cohorts) in patients with sickle cell disease (SCD) and vaso-occlusive crisis (VOC) who are at-risk for development of acute chest syndrome (ACS) based on the combination of VOC, fever (T ≥38.0ºC), and a serum sPLA2 concentration ≥50 ng/mL.

The first group of patients will be randomized 2:1 to receive low dose A-001 or placebo as a 48-hour continuous infusion. Pharmacokinetic and clinical data from this group will undergo review by the Independent Data Monitoring Committee (IDMC). If there is no significant toxicity associated with A-001, then an additional group of patients will be enrolled and randomized 2:1 to high dose A-001 versus placebo as a 48-hour continuous infusion.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome (Dose Escalation Study: Varespladib Infusion [A-001] for the Prevention of Acute Chest Syndrome in At-Risk Patients With Sickle Cell Disease and Vaso-occlusive Crisis)

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Other: Placebo Placebo
Experimental: A-001	Drug: A-001 A-001

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Other: Placebo

Placebo

Experimental: A-001

Drug: A-001

A-001

Outcome Measures

Primary Outcome Measures

To determine the safety and tolerability of different doses of A 001 therapy when administered as a 2-day continuous infusion to sickle cell disease (SCD) patients at-risk for the acute chest syndrome (ACS). [Study end]

Secondary Outcome Measures

To determine the pharmacokinetic profile of A-001 in SCD patients [Study end]
To confirm the ability of A-001 infusion to suppress serum sPLA2 activity in SCD patients with elevated serum sPLA2 [Study end]
To determine the efficacy of A-001 infusion in preventing ACS in SCD patients with the combination of vaso-occlusive crisis (VOC), fever, and elevated serum sPLA2 [Study end]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients are eligible for inclusion if they meet the following criteria:

Sickle cell variant (Hb SS, Hb SC, sickle β°-thalassemia, sickle β+-thalassemia)
Pain consistent with vaso-occlusive crisis
Elevated serum sPLA2 level (measured on-site)
Fever
Age ≥5 years (through adult)

Patients must NOT meet any of the following exclusion criteria:

New lung infiltrate by chest radiography
Pregnancy or breastfeeding
Significant renal dysfunction
Significant hepatic dysfunction
Acute neurologic dysfunction
Any medical condition for which transfusion may be needed imminently, and/or hemoglobin <5 g/dL
Red blood cell transfusion within 30 days of entry into the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howard University Hospital	Washington	District of Columbia	United States	20060
2	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30342
3	Children's Memorial Hospital	Chicago	Illinois	United States	60614
4	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
5	Duke University Comprehensive Sickle Cell Center	Durham	North Carolina	United States	27713
6	Virginia Commonwealth University	Richmond	Virginia	United States	23219

Sponsors and Collaborators

Anthera Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthera Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00434473

Other Study ID Numbers:

AN-SCD1121

First Posted:

Feb 13, 2007

Last Update Posted:

Mar 4, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Acute Chest Syndrome

Anemia, Sickle Cell

Syndrome

Study Results

No Results Posted as of Mar 4, 2014