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

Icagen

Status and phase

Terminated

Phase 3

Conditions

Sickle Cell Anemia

Sickle Cell Disease

Treatments

Drug: ICA-17043

Study type

Interventional

Funder types

Industry

Identifiers

NCT00294541

ICA-17043-12

Details and patient eligibility

About

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

Enrollment

51 patients

Sex

All

Ages

17 to 66 years old

Volunteers

No 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