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

• Sponsor: Anthera Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01522196
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Days): 29
• Patients Per Site Per Month: 2.1

Study Details

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).

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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.
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

2. Impact of A-001 treatment on sPLA2 levels and CRP. [Various time points up to Day 30]

3. Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis. [Various time points up to Day 30]

4. Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis. [Various time points up to Day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site 101	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Anthera Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthera Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01522196
• Other Study ID Numbers: AN-SCD1122
• First Posted: Jan 31, 2012
• Last Update Posted: Mar 4, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Anthera Pharmaceuticals: SCD
• Additional relevant MeSH terms: Anemia, Sickle Cell; Varespladib methyl

Study Results

No Results Posted as of Mar 4, 2014