Sickle Cell DiseasePhase 3ASSERTNCT00102791
A Stratified Sickle Event Randomized Trial (ASSERT)
A Phase 3 study testing ICA-17043 in people with Sickle Cell Disease, run by Icagen at 49 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- ICA-17043
- How many people
- 297 participants
- Where
- 49 sitesin 6 countries
- Study dates
- Feb 2005to 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States42 sites
Study site
Augusta, Georgia
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Brooklyn, New York
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Davis, California
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Greenville, North Carolina
Study site
Hackensack, New Jersey
Study site
Hartford, Connecticut
Study site
Holly Hill, Florida
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Iowa City, Iowa
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Mobile, Alabama
Study site
Nashville, Tennessee
Study site
New Brunswick, New Jersey
Study site
New Orleans, Louisiana
Study site
Newark, New Jersey
Study site
Oakland, California
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
Savannah, Georgia
Study site
Shreveport, Louisiana
Study site
The Bronx, New York
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
Brazil3 sites
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
São Paulo
About this study
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
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.
- Conditions
- Sickle Cell Disease
- Being tested
- ICA-17043
- Keywords
- 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.
Sickle Cell Crisis Rate
Measured: 52 weeks
Secondary outcomes (5)
Time to First, Second, and Third Crisis
Measured: 52 Weeks
Maximum Crisis Morbidity Ranking
Measured: 52 Weeks
Efficacy Related Laboratory Parameters
Measured: 52 Weeks
Quality of Life
Measured: 52 Weeks
Health Economics
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startFeb 2005
- Study completionJun 2007
Why it stopped: Because of the low probability of achieving the primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Investigators
- Jonathan W Stocker, Ph.D., Study director, Icagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102791
- Sponsor's protocol ID
- ICA-17043-10
- Acronym
- ASSERT
- Status last verified
- Sep 2007
- First submitted
- 1 Feb 2005
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00102791
- Acronym / sponsor ID
- ASSERT / ICA-17043-10
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the low probability of achieving the primary endpoint.
- Enrolment
- 297 participants (actual)
- Lead sponsor
- IcagenIndustry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Feb 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 2 Feb 2005 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
Sickle Cell Crisis Rate
Time frame: 52 weeks
5 secondary outcomes
Time to First, Second, and Third Crisis
Time frame: 52 Weeks
Maximum Crisis Morbidity Ranking
Time frame: 52 Weeks
Efficacy Related Laboratory Parameters
Time frame: 52 Weeks
Quality of Life
Time frame: 52 Weeks
Health Economics
Time frame: 52 Weeks
Results and safety
The study was stopped early (reason given: Because of the low probability of achieving the primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
- Background: PubMed 12433690Stocker 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.
- Icagen webpageLink provided by the sponsor.
Related trials for Sickle Cell Disease
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Active, not recruitingPhase 2/3
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Sickle Cell Disease
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
RecruitingPhase 1/2
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
Myeloid Chimerism
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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, Ph.D. study director
Icagen
49 sites in 6 countries: 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, run by Icagen at 49 sites in 6 countries.
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 3 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 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Brazil, France, Jamaica, Trinidad and Tobago and 1 more country. 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: Because of the low probability of achieving the primary endpoint.). 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?
Sickle Cell Crisis Rate (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102791, which also lists 1 linked publication.
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 27 Mar 2008.