CClinicalTrials.gg
TerminatedNCT00102791ASSERTUpdated Mar 27, 2008

A Stratified Sickle Event Randomized Trial (ASSERT)

A Phase 3 interventional study of ICA-17043 in Sickle Cell Disease, sponsored by Icagen. Terminated at 49 sites in 6 countries. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-03-27.

Sponsored by Icagen · Phase 3, Interventional, and Treatment

Why this study was terminated
Because of the low probability of achieving the primary endpoint.
Phase
Phase 3
Study type
Interventional
Enrollment
297
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sickle Cell Disease

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Keywords

  • Sickle Cell Anemia
03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 297 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Icagen is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
297 participants (actual)

Interventions

  • DrugICA-17043
06

What researchers measure

Primary outcomes

  1. Sickle Cell Crisis Rate

    Time frame: 52 weeks

Secondary outcomes

  1. Time to First, Second, and Third Crisis

    Time frame: 52 Weeks

  2. Maximum Crisis Morbidity Ranking

    Time frame: 52 Weeks

  3. Efficacy Related Laboratory Parameters

    Time frame: 52 Weeks

  4. Quality of Life

    Time frame: 52 Weeks

  5. Health Economics

    Time frame: 52 Weeks

07

Study locations

49 sites
  • Mobile, Alabama, United States
  • Little Rock, Arkansas, United States
  • Davis, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • Denver, Colorado, United States
  • Hartford, Connecticut, United States
  • Washington, District of Columbia, United States
  • Holly Hill, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Augusta, Georgia, United States
  • Savannah, Georgia, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • New Orleans, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Jackson, Mississippi, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Hackensack, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • Newark, New Jersey, United States
  • Bronx, New York, United States
  • Brooklyn, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Greenville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Memphis, Tennessee, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Richmond, Virginia, United States
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Sao Paulo, Brazil
  • Creteil, France
  • Kingston, Jamaica
  • Port of Spain, Trinidad and Tobago
  • London, United Kingdom
08

References and documents

Publications

  • 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. PubMed 12433690 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00102791
Lead sponsor
Icagen
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted
Feb 2, 2005
Start date
Feb 2005
Completion
Jun 2007
Last update
Mar 27, 2008

Study contacts

Jonathan W Stocker, Ph.D.
study director · Icagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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