Clinical Trial: A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Multicenter, Twelve-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Study of the Efficacy and Safety of ICA-17043 With or Without Hydroxyurea Therapy
Brief Summary: ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel in human red blood cells (RBCs) that blocks RBC dehydration. ICA-17043 is expected to inhibit RBC dehydration and thus should prevent or delay the sickling process. By reducing sickled cells, an improvement in anemia, a reduction in painful crises, and ultimately, less end-organ disease is anticipated.
Detailed Summary:
Sponsor: Icagen
Current Primary Outcome: The primary efficacy endpoint was the change from Baseline in hemoglobin (Hb) [ Time Frame: 12 Weeks ]
Original Primary Outcome:
Current Secondary Outcome:
- Changes in other hematologic measurements [ Time Frame: 12 weeks ]
- Changes in RBC indices, including: mean corpuscular volume (MCV), mean corpuscular Hb concentration (MCHC), and mean corpuscular Hb (MCH [ Time Frame: 12 weeks ]
- Other laboratory measures associated with sickle cell crises activity including: direct and indirect bilirubin and lactic dehydrogenase (LDH) [ Time Frame: 12 weeks ]
- Rate of painful crises [ Time Frame: 12 weeks ]
- Time to first painful crisis [ Time Frame: 12 weeks ]
- Morbidity of painful crises (maximum morbidity index, derived variable) [ Time Frame: 12 weeks ]
- Pain intensity scores [ Time Frame: 12 weeks ]
- Quality of Life (SF 36) [ Time Frame: 12 Weeks ]
- Health economic data [ Time Frame: 12 weeks ]
- Average plasma concentration [ Time Frame: 12 weeks ]
- Correlation between the average plasma concentration and the change in Hb from Baseline to study endpoint [ Time Frame: 12 weeks ]
Original Secondary Outcome:
Information By: Icagen
Dates:
Date Received: July 8, 2002
Date Started: February 2002
Date Completion:
Last Updated: July 13, 2011
Last Verified: July 2011