C07-001: Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 29
• Participant gender: Both

Summary

Assess the safety and efficacy of Eculizumab in hemolytic PNH patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Collaborator: CMIC Co, Ltd. Japan
• Last Updated: 2012-04-04

Criteria

Inclusion Criteria:

• Japanese individuals at least 12 years of age

• Diagnosis of PNH > 6 months

• One transfusion in the past two years for anemia or anemia-related symptoms

• LDH level >/= 1.5 x upper limit of normal within 12 weeks

Exclusion Criteria:

• Platelet count < 30,000/microliters

• Known or suspected hereditary complement deficiency

• History of hematopoietic stem cell transplant

• History of meningococcal disease