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A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

Primary Purpose

Sickle Cell Disease, Sickle Cell Anemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ICA-17043
Sponsored by
Icagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring sickle cell disease, sickle cell anemia

Eligibility Criteria

17 Years - 66 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of South Alabama
  • Arkansas Children's Hospital
  • Children's Hospital Oakland
  • University of California Davis Medical Center
  • University of Colorado Health Sciences Center
  • Century Clinical Research, Inc.
  • University of Florida Health Science Center
  • Medical College of Georgia
  • Memorial Health University Medical Center
  • University of Illinois Medical Center
  • Sickle Cell Center of Northern Louisiana
  • Johns Hopkins University School of Medicine
  • Brigham and Women's Hospital
  • Wayne State School of Medicine
  • University of Mississippi Medical Center
  • Hackensack University Medical Center
  • Robert Wood Johnson Medical Center
  • Newark Beth Israel Medical Center
  • SUNY Downstate Medical Center
  • New York Methodist Hospital
  • University of North Carolina Hospitals
  • Duke University Medical Center
  • East Carolina University School of Medicine
  • Wake Forest University School of Medicine
  • University of Cincinnati
  • Thomas Jefferson University Hospital
  • St. Christopher's Hospital for Children
  • Medical University of South Carolina
  • Baylor College of Medicine
  • Medical College of Virginia
  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

Safety measures only
No efficacy outcome measures

Secondary Outcome Measures

Full Information

First Posted
February 21, 2006
Last Updated
September 10, 2007
Sponsor
Icagen
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00294541
Brief Title
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy demonstrated in study ICA-17043-10
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Icagen
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle Cell Anemia
Keywords
sickle cell disease, sickle cell anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ICA-17043
Primary Outcome Measure Information:
Title
Safety measures only
Time Frame
at least 60 weeks
Title
No efficacy outcome measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Stocker, PhD
Organizational Affiliation
Icagen
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Century Clinical Research, Inc.
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Sickle Cell Center of Northern Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wayne State School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112-2027
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0157
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

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