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

Sickle Cell Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522196
• Other study ID #: AN-SCD1122
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2012
• Last updated: January 30, 2014
• Start date: February 2012
• Est. completion date: March 2012

Study information

• Verified date: January 2014
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Genotypes Hb SS, Hb SC, sickle ß°-thalassemia, sickle ß+ -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

Study Design

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vaso-occlusive Crisis

Intervention

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.

Locations

Country	Name	City	State
United States	Investigator Site 101	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Various time points up to Day 30	Yes
Secondary	Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.		Various time points up to Day 30	Yes
Secondary	Impact of A-001 treatment on sPLA2 levels and CRP.		Various time points up to Day 30	Yes
Secondary	Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.		Various time points up to Day 30	Yes
Secondary	Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.		Various time points up to Day 30	No