Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01412047

Enrollment

Registered

2011-08-08

Start date

2012-03-31

Completion date

2013-06-30

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Nocturnal Hemoglobinuria, PNH

Keywords

Paroxysmal Nocturnal Hemoglobinuria, PNH, Human Anti-Human Antibody, HAHA, Soliris, eculizumab

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
To summarize the proportion of patients with neutralizing HAHA antibodies.	Six (6) months

Secondary

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

Countries

Australia, Belgium, France, Germany, Ireland, Italy, Netherlands, Switzerland, United Kingdom, United States

Outcome results