Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

Alexion Pharmaceuticals

Status: Completed

Conditions: PNH; Paroxysmal Nocturnal Hemoglobinuria

Study type: Observational

Funder types: Industry

Identifiers

NCT01412047

M07-003

Details and patient eligibility

About

How does long term treatment with Soliris affect HAHA in PNH patients?

Full description

To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• PNH patients who previously participated in study E05-001;
• Patients who have an eculizumab naive serum sample for comparison;
• Patients who currently used commerical Soliris;
• Patients who are willing and able to gie written informed consent.

Exclusion criteria

• There are no exclusion criteria for this study.