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
  Purpose

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).


Condition Intervention Phase
Sickle Cell Disease
Vaso-occlusive Crisis
Drug: Varespladib
Other: Placebo (Normal Saline)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

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). [ Time Frame: Various time points up to Day 30 ] [ Designated as safety issue: Yes ]

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. [ 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 ]

Enrollment: 2
Study Start Date: February 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Varespladib
48 hour continuous infusion delivered intravenously (IV)
Drug: Varespladib
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
Placebo Comparator: Placebo
48 hour continuous infusion delivered intravenously (IV)
Other: Placebo (Normal Saline)
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522196

Locations
United States, Georgia
Investigator Site 101
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522196     History of Changes
Other Study ID Numbers: AN-SCD1122
Study First Received: January 18, 2012
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
SCD

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014