Clinical Trial: Therapy of Chronic Cold Agglutinin Disease With Eculizumab
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Usin
Brief Summary: Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)
Detailed Summary:
Sponsor: University Hospital, Essen
Current Primary Outcome: LDH [ Time Frame: From baseline to 26 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Transfusion avoidance [ Time Frame: From baseline to 26 weeks ]
- PRBC units transfused [ Time Frame: From baseline to 26 weeks ]
- Change in hemoglobin levels [ Time Frame: From baseline to 26 weeks ]
- Haptoglobin [ Time Frame: From baseline to 26 weeks ]
- Hemopexin [ Time Frame: From baseline to 26 weeks ]
- Free hemoglobin [ Time Frame: From baseline to 26 weeks ]
- Reticulocytes [ Time Frame: From baseline to 26 weeks ]
- SF-36v2 QLQ [ Time Frame: From baseline to 26 weeks ]
- FACIT-F SCALE version 4 [ Time Frame: From baseline to 26 weeks ]
- Six-Minute Walk Test [ Time Frame: From baseline to 26 weeks ]
- Circulatory symptoms [ Time Frame: From baseline to 26 weeks ]
- Thrombosis record [ Time Frame: From baseline to 26 weeks ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Essen
Dates:
Date Received: February 24, 2011
Date Started: February 2011
Date Completion:
Last Updated: August 3, 2015
Last Verified: August 2015