Paroxysmal Nocturnal Hemoglobinuria Hum… | Clinical Trial

Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes PNH

Sex eligibility

All sexes

Study type

Observational

Primary location

Melbourne, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

To summarize the proportion of patients with neutralizing HAHA antibodies.

Time frame: Six (6) months

Secondary outcomes

To summarize the proportion of patients with non-neutralizing HAHA antibodies.

Time frame: Six (6) months
To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies.

Time frame: Six (6) months

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 8, 2011
Registry last updated: Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed