Study Stopped
Lack of efficacy demonstrated in study ICA-17043-10
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease
1 other identifier
interventional
51
1 country
31
Brief Summary
This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III, multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD) (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12). Only patients who participated in ICA-17043-10 are eligible for this open label study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2006
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 21, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedSeptember 11, 2007
September 1, 2007
February 21, 2006
September 10, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety measures only
at least 60 weeks
No efficacy outcome measures
Interventions
Eligibility Criteria
You may qualify if:
- Successfully completed Study ICA-17043-10
- Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1
- Male, or female not capable of becoming pregnant or using appropriate birth control
- Has willingly given written informed consent to participate in this study
You may not qualify if:
- The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study)
- The subject is presently unsuitable for participation in this long-term study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of South Alabama
Mobile, Alabama, 36617, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Oakland
Oakland, California, 94609, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Century Clinical Research, Inc.
Holly Hill, Florida, 32117, United States
University of Florida Health Science Center
Jacksonville, Florida, 32209, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Sickle Cell Center of Northern Louisiana
Shreveport, Louisiana, 71103, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Wayne State School of Medicine
Detroit, Michigan, 48201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112-2027, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical College of Virginia
Richmond, Virginia, 23298-0157, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonathan W Stocker, PhD
Icagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 21, 2006
First Posted
February 22, 2006
Study Start
February 1, 2006
Study Completion
June 1, 2007
Last Updated
September 11, 2007
Record last verified: 2007-09