A Stratified Sickle Event Randomized Trial (ASSERT)

Sickle Cell Disease Clinical Trial

— ASSERT  

Official title:

A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00102791
• Other study ID #: ICA-17043-10
• Status: Terminated
• Phase: Phase 3
• First received: February 1, 2005
• Last updated: March 26, 2008
• Start date: February 2005
• Est. completion date: June 2007

Study information

• Verified date: September 2007
• Source: Icagen
• 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 compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 297
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• 16 to 65 years of age (inclusive)

• Male or female (not capable of becoming pregnant or using appropriate birth control)

• Medical history of sickle cell disease

• Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months

Exclusion Criteria:

• Hemoglobin <4 or >11 g/dL

• On a chronic transfusion program

• Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• ICA-17043

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Icagen	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  France,  Jamaica,  Trinidad and Tobago,  United Kingdom, 

References & Publications (1)

Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. Epub 2002 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sickle Cell Crisis Rate		52 weeks
Secondary	Time to First, Second, and Third Crisis		52 Weeks
Secondary	Maximum Crisis Morbidity Ranking		52 Weeks
Secondary	Efficacy Related Laboratory Parameters		52 Weeks
Secondary	Quality of Life		52 Weeks
Secondary	Health Economics		52 Weeks

External Links

•   Icagen webpage