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

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294541
• Other study ID #: ICA-17043-12
• Status: Terminated
• Phase: Phase 3
• First received: February 21, 2006
• Last updated: September 10, 2007
• Start date: February 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2007
• Source: Icagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 66 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia
• Sickle Cell Disease

Intervention

Drug:
• ICA-17043

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Wayne State School of Medicine	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Century Clinical Research, Inc.	Holly Hill	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Florida Health Science Center	Jacksonville	Florida
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of South Alabama	Mobile	Alabama
United States	Robert Wood Johnson Medical Center	New Brunswick	New Jersey
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Children's Hospital Oakland	Oakland	California
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Medical College of Virginia	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California Davis Medical Center	Sacramento	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Sickle Cell Center of Northern Louisiana	Shreveport	Louisiana
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Icagen	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures only		at least 60 weeks
Primary	No efficacy outcome measures