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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01412047




Registration number
NCT01412047
Ethics application status
Date submitted
5/08/2011
Date registered
8/08/2011
Date last updated
18/10/2017

Titles & IDs
Public title
Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
Scientific title
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
Secondary ID [1] 0 0
M07-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Nocturnal Hemoglobinuria 0 0
PNH 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To summarize the proportion of patients with neutralizing HAHA antibodies.
Timepoint [1] 0 0
Six (6) months
Secondary outcome [1] 0 0
To summarize the proportion of patients with non-neutralizing HAHA antibodies.
Timepoint [1] 0 0
Six (6) months
Secondary outcome [2] 0 0
To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies.
Timepoint [2] 0 0
Six (6) months

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There are no exclusion criteria for this study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2013
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Germany
State/province [7] 0 0
Ulm
Country [8] 0 0
Ireland
State/province [8] 0 0
Dublin
Country [9] 0 0
Italy
State/province [9] 0 0
Firenze
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nijmegen
Country [12] 0 0
Switzerland
State/province [12] 0 0
Basel
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
How does long term treatment with Soliris affect HAHA in PNH patients?
Trial website
https://clinicaltrials.gov/ct2/show/NCT01412047
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Camille Bedrosian, MD
Address 0 0
Alexion Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01412047