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Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

NCT ID: NCT01412047

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Paroxysmal Nocturnal Hemoglobinuria PNH

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille Bedrosian, MD

Role: STUDY_DIRECTOR

Alexion Pharmaceuticals, Inc.

Locations

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University Park Hematology Oncology

Englewood, Colorado, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Maine Cancer Center of Medicine

Scarborough, Maine, United States

Site Status

Melbourne, , Australia

Site Status

Brussels, , Belgium

Site Status

Paris, , France

Site Status

Universitatsklinikum Essen

Essen, , Germany

Site Status

Institut fur Klinische Transfusionmedizin und Immungenetick

Ulm, , Germany

Site Status

Dublin, , Ireland

Site Status

Azienda Ospediliera Universitatia Careggi

Florence, , Italy

Site Status

Universita degli Studi di Napoli

Napoli, , Italy

Site Status

Nijmegen, , Netherlands

Site Status

Basel, , Switzerland

Site Status

London, , United Kingdom

Site Status

Countries

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Canada Spain Sweden United States Australia Belgium France Germany Ireland Italy Netherlands Switzerland United Kingdom

Other Identifiers

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M07-003

Identifier Type: -

Identifier Source: org_study_id