NCT00294541

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

An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Icagen · Industry
• Sex: All
• Age: 17 Years – 66 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sickle Cell Disease
• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	ICA-17043

Timeline

• Start date: 2006-02-01
• Completion: 2007-06-01
• First posted: 2006-02-22
• Last updated: 2007-09-11

Locations

31 sites across 1 country: United States