Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

October 16, 2017 updated by: Alexion Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
  • Belgium
      • Brussels, Belgium
  • France
      • Paris, France
  • Germany
      • Essen, Germany
        • Universitätsklinikum Essen
      • Ulm, Germany
        • Institut fur Klinische Transfusionmedizin und Immungenetick
  • Ireland
      • Dublin, Ireland
  • Italy
      • Firenze, Italy
        • Azienda Ospediliera Universitatia Careggi
      • Napoli, Italy
        • Universita degli Studi di Napoli
  • Netherlands
      • Nijmegen, Netherlands
  • Switzerland
      • Basel, Switzerland
  • United Kingdom
      • London, United Kingdom
  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • University Park Hematology Oncology
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Cancer Center of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with PNH previously enrolled in study E05-001, who have a eculizumab naive serum sample available for comparison, and who are currently receiving treatment with commerical Soliris.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Investigators

  • Study Director: Camille Bedrosian, MD, Alexion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 30, 2013

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (ESTIMATE)

August 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M07-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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