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European Sickle Cell Disease Cohort - Hydroxyurea (ESCORT-HU)

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.
 
ClinicalTrials.gov Identifier: NCT02516579
Recruitment Status : Completed
First Posted : August 6, 2015
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
ADDMEDICA SASA

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Sickle Cell Disease
Intervention Drug: Siklos
Enrollment 1906
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
Period Title: Overall Study
Started 1906
Completed 1906
Not Completed 0
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
Overall Number of Baseline Participants 1903
Hide Baseline Analysis Population Description
1906 patients included but 1903 patient took at least one dose of Siklos and are included in the analysis
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1903 participants
21.4
(0.8 to 70.4)
[1]
Measure Analysis Population Description: 1906 patients were included but 1903 patients took at least one dose of Siklos and were included in the analysis
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1903 participants
Female
1051
  55.2%
Male
852
  44.8%
[1]
Measure Analysis Population Description: 1906 patients were included but 1903 patient took at least one dose of Siklos and were included in the analysis
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 1903 participants
173
Italy Number Analyzed 1903 participants
10
France Number Analyzed 1903 participants
1575
Germany Number Analyzed 1903 participants
145
[1]
Measure Analysis Population Description: 1906 patients were included but 1903 took at least one dose of Siklos and were included in the analysis
1.Primary Outcome
Title % of Patient-years With Malignancies
Hide Description [Not Specified]
Time Frame During the follow-up of participant, up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with follow-up visit
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description:
The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
Overall Number of Participants Analyzed 1854
Measure Type: Number
Unit of Measure: % patient-years
0.001
2.Primary Outcome
Title % of Patient-years With Skin Ulcerations
Hide Description Patients with at least one skin ulceration
Time Frame During the follow-up of participant, up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description:
The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
Overall Number of Participants Analyzed 1854
Measure Type: Number
Unit of Measure: % patient-years
1.13
3.Primary Outcome
Title % of Patient-years With Myelosuppressions
Hide Description Patients with at least one myelosuppression
Time Frame During the follow-up of participant, up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description:
The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
Overall Number of Participants Analyzed 1854
Measure Type: Number
Unit of Measure: % patient-years
5.99
Time Frame Adverse events were collected during the follow-up of participant, up to 10 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Sickle Cell Disease Treated With Siklos®
Hide Arm/Group Description The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
All-Cause Mortality
Patients With Sickle Cell Disease Treated With Siklos®
Affected / at Risk (%)
Total   33/1903 (1.73%) 
Hide Serious Adverse Events
Patients With Sickle Cell Disease Treated With Siklos®
Affected / at Risk (%)
Total   705/1903 (37.05%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders * 1  155/1903 (8.15%) 
General disorders   
general disorders and administration site conditions * 1  97/1903 (5.10%) 
Infections and infestations   
infections and infestations * 1  346/1903 (18.18%) 
Respiratory, thoracic and mediastinal disorders   
respiratory, thoracic and mediastinal disorders * 1  151/1903 (7.93%) 
1
Term from vocabulary, MedDRA (19.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Sickle Cell Disease Treated With Siklos®
Affected / at Risk (%)
Total   1308/1903 (68.73%) 
General disorders   
General disorders and administration site conditions * 1  386/1903 (20.28%) 
Infections and infestations   
infections and infestations * 1  645/1903 (33.89%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders * 1  370/1903 (19.44%) 
1
Term from vocabulary, MedDRA (19.1)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical director
Organization: Addmedica
Phone: +33172690186
EMail: corinne.duguet@addmedica.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT02516579    
Other Study ID Numbers: ESCORT-HU
First Submitted: July 23, 2015
First Posted: August 6, 2015
Results First Submitted: February 18, 2020
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020