Trial record 3 of 39 for:    "paroxysmal nocturnal hemoglobinuria"

Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01412047
First received: August 5, 2011
Last updated: July 9, 2013
Last verified: July 2013
  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:


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.

  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
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
  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: July 9, 2013
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 April 17, 2014