Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

This study has been completed.
Information provided by (Responsible Party):
Alexion Pharmaceuticals Identifier:
First received: August 5, 2011
Last updated: July 9, 2013
Last verified: July 2013
How does long term treatment with Soliris affect HAHA in PNH patients?

Paroxysmal Nocturnal Hemoglobinuria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Resource links provided by NLM:

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • To summarize the proportion of patients with neutralizing HAHA antibodies. [ Time Frame: Six (6) months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To summarize the proportion of patients with non-neutralizing HAHA antibodies. [ Time Frame: Six (6) months ] [ Designated as safety issue: No ]
  • To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies. [ Time Frame: Six (6) months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01412047

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

Responsible Party: Alexion Pharmaceuticals Identifier: NCT01412047     History of Changes
Other Study ID Numbers: M07-003 
Study First Received: August 5, 2011
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alexion Pharmaceuticals:
Paroxysmal Nocturnal Hemoglobinuria
Human Anti-Human Antibody

Additional relevant MeSH terms:
Hemoglobinuria, Paroxysmal
Anemia, Hemolytic
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations processed this record on May 23, 2016