Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

N/ACompletedNCT01412047

Alexion Pharmaceuticals, Inc.75 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Paroxysmal Nocturnal Hemoglobinuria PNH

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (14)

University Park Hematology Oncology

Englewood, Colorado, United States

Cleveland Clinic Florida

Weston, Florida, United States

Maine Cancer Center of Medicine

Scarborough, Maine, United States

Outcomes

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

Data from ClinicalTrials.gov

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