Clinical Trial: E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
Brief Summary: The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.
Detailed Summary:
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome: Safety and Efficacy of Eculizumab treatment [ Time Frame: Baseline through Week 26 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change of LDH [ Time Frame: From baseline ]
- Change of total scores of FACIT-Fatigue scale [ Time Frame: From baseline ]
- Change of PNH RBC [ Time Frame: From baseline ]
- Number of units of Packed RBCs transfused [ Time Frame: From baseline ]
- Lactate dehydrogenase (LDH) area under the curve (AUC) [ Time Frame: From baseline ]
- Change of plasma free Hemoglobin [ Time Frame: From baseline ]
- Change of total EORTC QLQ-C30 score [ Time Frame: From baseline ]
Original Secondary Outcome: Same as current
Information By: Alexion Pharmaceuticals
Dates:
Date Received: August 30, 2010
Date Started: April 2008
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017
