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Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412047
First Posted: August 8, 2011
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
  Purpose
How does long term treatment with Soliris affect HAHA in PNH patients?

Condition
Paroxysmal Nocturnal Hemoglobinuria PNH

Study Type: Observational
Study Design: Observational Model: Other
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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: March 2012
Study Completion Date: June 30, 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412047


Locations
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
Australia
Melbourne, Australia
Belgium
Brussels, Belgium
France
Paris, France
Germany
Universitatsklinikum Essen
Essen, Germany
Institut fur Klinische Transfusionmedizin und Immungenetick
Ulm, Germany
Ireland
Dublin, Ireland
Italy
Azienda Ospediliera Universitatia Careggi
Firenze, Italy
Universita degli Studi di Napoli
Napoli, Italy
Netherlands
Nijmegen, Netherlands
Switzerland
Basel, Switzerland
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Alexion Pharmaceuticals
Investigators
Study Director: Camille Bedrosian, MD Alexion Pharmaceuticals
  More Information

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01412047     History of Changes
Other Study ID Numbers: M07-003
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs