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Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Alexion Pharmaceuticals
Sponsor:
Collaborator:
ICON
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01374360
First received: April 15, 2011
Last updated: September 9, 2014
Last verified: September 2014
History of Changes

April 15, 2011
September 9, 2014
January 2007
December 2020   (final data collection date for primary outcome measure)
The PNH Registry will collect data to evaluate safety data specific to the use of Soliris. [ Time Frame: Ongoing (up to 13 years) ] [ Designated as safety issue: Yes ]
Primary analyses will assess safety endpoints, including occurrence and time to first event for the following: meningococcal infections, infections with serious outcomes, formation of HAHA to Soliris, malignancy, thrombotic events, pulmonary hypertension, impaired renal function, serious hemolysis, pregnancies, infusion reactions, targeted adverse events, bone marrow transplant, and mortality.
Same as current
Complete list of historical versions of study NCT01374360 on ClinicalTrials.gov Archive Site
PNH Registry will collect data to characterize the progression of PNH as well as clinical outcomes, mortality and morbidity in Soliris and non-Soliris treated patients. [ Time Frame: Ongoing (up to 13 years) ] [ Designated as safety issue: No ]
Secondary analyses will include descriptions of patient populations, PNH specific treatments, concomitant medications, progression of disease, PNH clone sites, clinical symptoms, and clinical outcomes.
Same as current
Not Provided
Not Provided
 
Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

This study is a collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).

Collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

PNH Patients
Paroxysmal Nocturnal Hemoglobinuria
Not Provided
  • Receiving Soliris
    PNH patients of any age, including minors, that are receiving Soliris
  • Not receiving Soliris
    PNH patients of any age, including minors, that are not receiving Soliris
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of any age, including minors, with a diagnosis of PNH or a detected PNH clone, including patients previously treated with Soliris and withdrawn from treatment. (Subjects under the age of eighteen years must have parent/legal guardian consent. Upon turning eighteen years of age, these subjects must be re-consented).
  • Ability to comprehend and sign consent to have data entered in the PNH Registry.
Both
Not Provided
No
Contact: Lynn Sanders 203-439-9609 sandersl@alxn.com
United States
 
NCT01374360
M07-001
Yes
Alexion Pharmaceuticals
Alexion Pharmaceuticals
ICON
Study Director: Stephen Squinto, PhD Alexion Pharmaceuticals
Alexion Pharmaceuticals
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP