Clinical trial NCT00102791: A Stratified Sickle Event Randomized 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Anemia
Lead sponsor: Icagen
Sponsor class: INDUSTRY
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2005-02-02
Enrollment: 297
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sickle Cell Crisis Rate
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to First, Second, and Third Crisis
timeFrame: 52 Weeks
measure: Maximum Crisis Morbidity Ranking
timeFrame: 52 Weeks
measure: Efficacy Related Laboratory Parameters
timeFrame: 52 Weeks
measure: Quality of Life
timeFrame: 52 Weeks
measure: Health Economics
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Davis
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Holly Hill
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Creteil
country: France
city: Kingston
country: Jamaica
city: Port of Spain
country: Trinidad and Tobago
city: London
country: United Kingdom
Study officials:
affiliation: Icagen
name: Jonathan W Stocker, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1182/blood-2002-05-1433. Epub 2002 Nov 14.