Sickle Cell DiseasePhase 3NCT00294541
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
A Phase 3 study testing ICA-17043 in people with Sickle Cell Disease and Sickle Cell Anemia, run by Icagen at 31 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 66 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Anemia
- What is being tested?
- ICA-17043
- How many people
- 51 participants
- Where
- 31 sitesUnited States
- Study dates
- Feb 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 66 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Medical College of Georgia
Augusta, Georgia, 30912
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Brigham and Women's Hospital
Boston, Massachusetts, 02115
SUNY Downstate Medical Center
Brooklyn, New York, 11203
New York Methodist Hospital
Brooklyn, New York, 11215
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45219
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Wayne State School of Medicine
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University School of Medicine
Greenville, North Carolina, 27858
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Century Clinical Research, Inc.
Holly Hill, Florida, 32117
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Florida Health Science Center
Jacksonville, Florida, 32209
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of South Alabama
Mobile, Alabama, 36617
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, 07112-2027
Children's Hospital Oakland
Oakland, California, 94609
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
Medical College of Virginia
Richmond, Virginia, 23298-0157
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California Davis Medical Center
Sacramento, California, 95817
Memorial Health University Medical Center
Savannah, Georgia, 31404
Sickle Cell Center of Northern Louisiana
Shreveport, Louisiana, 71103
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease
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
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia
- Being tested
- ICA-17043
- Keywords
- sickle cell disease, sickle cell anemia
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICA-17043Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures only
Measured: at least 60 weeks
No efficacy outcome measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionJun 2007
Why it stopped: Lack of efficacy demonstrated in study ICA-17043-10
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Investigators
- Jonathan W Stocker, PhD, Study director, Icagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294541
- Sponsor's protocol ID
- ICA-17043-12
- Status last verified
- Sep 2007
- First submitted
- 21 Feb 2006
- Last updated
- 11 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00294541
- Acronym / sponsor ID
- ICA-17043-12
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia
- Keywords
- sickle cell disease, sickle cell anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy demonstrated in study ICA-17043-10
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IcagenIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Feb 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICA-17043 | Drug | – |
Primary outcome
Safety measures only
Time frame: at least 60 weeks
No efficacy outcome measures
Results and safety
The study was stopped early (reason given: Lack of efficacy demonstrated in study ICA-17043-10). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Stocker, PhD study director
Icagen
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICA-17043 in people with Sickle Cell Disease and Sickle Cell Anemia, run by Icagen at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy demonstrated in study ICA-17043-10). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measures only (time frame: at least 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2007.