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

This study has been terminated.
(change in company plans)
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01522196
First received: January 18, 2012
Last updated: January 30, 2014
Last verified: January 2014

January 18, 2012
January 30, 2014
February 2012
March 2012   (final data collection date for primary outcome measure)
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: Various time points up to Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01522196 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome. [ Time Frame: Various time points up to Day 30 ] [ Designated as safety issue: Yes ]
  • Impact of A-001 treatment on sPLA2 levels and CRP. [ Time Frame: Various time points up to Day 30 ] [ Designated as safety issue: Yes ]
  • Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis. [ Time Frame: Various time points up to Day 30 ] [ Designated as safety issue: Yes ]
  • Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis. [ Time Frame: Various time points up to Day 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
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.

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Sickle Cell Disease
  • Vaso-occlusive Crisis
  • Drug: Varespladib
    48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
  • Other: Placebo (Normal Saline)
    48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
  • Active Comparator: Varespladib
    48 hour continuous infusion delivered intravenously (IV)
    Intervention: Drug: Varespladib
  • Placebo Comparator: Placebo
    48 hour continuous infusion delivered intravenously (IV)
    Intervention: Other: Placebo (Normal Saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01522196
AN-SCD1122
No
Anthera Pharmaceuticals
Anthera Pharmaceuticals
Not Provided
Not Provided
Anthera Pharmaceuticals
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP