Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

Completed

Conditions studied: Paroxysmal Nocturnal Hemoglobinuria, PNH

In brief

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

Key facts

Study ID

NCT01412047

Run by

Alexion Pharmaceuticals, Inc.

People needed

75

Starts

2012-03-01

Expected to finish

2013-06-30

Last updated by the study team

2017-10-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria for this study.

Where it is running

• University Park Hematology Oncology — Englewood, Colorado, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Maine Cancer Center of Medicine — Scarborough, Maine, United States
• Study site — Melbourne, Australia
• Study site — Brussels, Belgium
• Study site — Paris, France
• Universitatsklinikum Essen — Essen, Germany
• Institut fur Klinische Transfusionmedizin und Immungenetick — Ulm, Germany
• Study site — Dublin, Ireland
• Azienda Ospediliera Universitatia Careggi — Florence, Italy
• Universita degli Studi di Napoli — Naples, Italy
• Study site — Nijmegen, Netherlands
• Study site — Basel, Switzerland
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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