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A Study of Varespladib Infusion in Subjects With Sickle Cell Disease. (IMPACTS-2)

Primary Purpose

Sickle Cell Disease, Vaso-occlusive Crisis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Varespladib

Placebo (Normal Saline)

About this trial

This is an interventional prevention trial for Sickle Cell Disease focused on measuring SCD

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Genotypes Hb SS, Hb SC, sickle β°-thalassemia, sickle β+ -thalassemia
Pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes
Serum CRP ≥5.0 mg/L at time of screening
Fever defined as oral temperature ≥38.0°C at time of screening
Age ≥5 years

Exclusion Criteria:

New or suspected new pulmonary infiltrate diagnosed by chest radiography
Females who are nursing, pregnant or intend to become pregnant
Renal dysfunction defined as a creatinine level >1.2 mg/dL for subjects aged 18 or less or a creatinine level >1.5 mg/dL for subjects over the age of 18
Hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 × upper limit of normal)
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 prior to screening
Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening

Sites / Locations

Investigator Site 101

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varespladib

Placebo

Arm Description

48 hour continuous infusion delivered intravenously (IV)

Outcomes

Primary Outcome Measures

Efficacy of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with the combination of vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).

Secondary Outcome Measures

Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.

Impact of A-001 treatment on sPLA2 levels and CRP.

Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.

Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.

Full Information

NCT ID

NCT01522196

First Posted

January 18, 2012

Last Updated

January 30, 2014

Sponsor

Anthera Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01522196

Brief Title

A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.

Acronym

IMPACTS-2

Official Title

A Randomized, Double-blind, Placebo-Controlled Study With Varespladib Infusion (A-001) in Subjects With Sickle Cell Disease and Vaso-Occlusive Crisis for the Prevention of Acute Chest Syndrome At-Risk Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

change in company plans

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).

6. Conditions and Keywords

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

Sickle Cell Disease, Vaso-occlusive Crisis

Keywords

SCD

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varespladib

Arm Type

Active Comparator

Arm Description

48 hour continuous infusion delivered intravenously (IV)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

48 hour continuous infusion delivered intravenously (IV)

Intervention Type

Drug

Intervention Name(s)

Varespladib

Intervention Description

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Intervention Type

Other

Intervention Name(s)

Placebo (Normal Saline)

Intervention Description

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Primary Outcome Measure Information:

Title

Efficacy of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with the combination of vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).

Time Frame