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Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

This study is currently recruiting participants.
Verified November 2012 by Alexion Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01412047
First received: August 5, 2011
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Paroxysmal Nocturnal Hemoglobinuria
PNH

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:

Drug Information available for: Eculizumab
U.S. FDA Resources

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 ]

Estimated Enrollment: 170
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 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.

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412047

Locations
United States, Colorado
University Park Hematology Oncology Completed
Englewood, Colorado, United States, 80113
United States, Florida
Cleveland Clinic Florida Completed
Weston, Florida, United States, 33331
United States, Maine
Maine Cancer Center of Medicine Completed
Scarborough, Maine, United States, 04074
Australia
Completed
Melbourne, Australia
Belgium
Completed
Brussels, Belgium
France
Not yet recruiting
Paris, France
Germany
Universitatsklinikum Essen Completed
Essen, Germany
Institut fur Klinische Transfusionmedizin und Immungenetick Recruiting
Ulm, Germany
Contact: Jana Pasquet         pasquetj@alxn.com    
Ireland
Not yet recruiting
Dublin, Ireland
Italy
Azienda Ospediliera Universitatia Careggi Recruiting
Firenze, Italy
Contact: Jana Pasquet         pasquetj@alxn.com    
Universita degli Studi di Napoli Recruiting
Napoli, Italy
Contact: Jana Pasquet         pasquetj@alxn.com    
Netherlands
Completed
Nijmegen, Netherlands
Switzerland
Not yet recruiting
Basel, Switzerland
United Kingdom
Not yet recruiting
London, United Kingdom
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01412047     History of Changes
Other Study ID Numbers: M07-003
Study First Received: August 5, 2011
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alexion Pharmaceuticals:
Paroxysmal Nocturnal Hemoglobinuria
PNH
Human Anti-Human Antibody
 HAHA
Soliris
eculizumab

Additional relevant MeSH terms:
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013