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

Anthera Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Vaso-occlusive Crisis

Sickle Cell Disease

Treatments

Drug: Varespladib

Other: Placebo (Normal Saline)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01522196

AN-SCD1122

Details and patient eligibility

About

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).

Enrollment

2 patients

Sex

All

Ages

5+ years old

Volunteers

No 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