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

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 ]

Primary endpoint for this study is: lactate dehydrogenase (LDH) in U/l change 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