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In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siklos | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of Patient-years With Malignancies | During the follow-up of participant, up to 10 years | |
| % of Patient-years With Skin Ulcerations | Patients with at least one skin ulceration | During the follow-up of participant, up to 10 years |
| % of Patient-years With Myelosuppressions | Patients with at least one myelosuppression | During the follow-up of participant, up to 10 years |
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Inclusion Criteria:
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Patient with sickle-cell disease
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Galacteros, MD | Hôpital henri Mondor (Adults) | Principal Investigator |
| Mariane de Montalembert, MD | Hôpital Necker Enfants Malades (Children) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens - Picardie - Site sud | Amiens | France | ||||
| Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38247384 | Derived | Allali S, Galacteros F, Oevermann L, Cannas G, Joseph L, Loko G, Elenga N, Benkerrou M, Etienne-Julan M, Castex MP, Brousse V, de Montalembert M. Hydroxyurea is associated with later onset of acute splenic sequestration crisis in sickle cell disease: Lessons from the European Sickle Cell Disease Cohort-Hydroxyurea (ESCORT-HU) study. Am J Hematol. 2024 Apr;99(4):555-561. doi: 10.1002/ajh.27214. Epub 2024 Jan 22. | |
| 34224583 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Sickle Cell Disease Treated With Siklos® | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2017 |
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| Aulnay-sous-Bois |
| 93602 |
| France |
| Hôpital Avicenne; médecine interne | Bobigny | 93009 | France |
| Hôpital Jean Verdier; médecine interne | Bondy | 93143 | France |
| Hôpital Jean Verdier; pédiatrie | Bondy | 93143 | France |
| CHU Bordeaux, urgences pédiatriques | Bordeaux | 33000 | France |
| Hôpital Saint-André | Bordeaux | France |
| CHU Estaing, pédiatrie | Clermont-Ferrand | 63003 | France |
| Hôpital Louis Mourier; pédiatrie | Colombes | 92700 | France |
| Hôpital Louis Mourier; service de pédiatrie | Colombes | 92700 | France |
| Centre hospitalier intercommunal de Créteil | Créteil | 94010 | France |
| Hôpital Henri Mondor, centre de la Drépanocytose | Créteil | 94010 | France |
| Centre Hospitalier de Gonesse, médecine interne | Gonesse | 95500 | France |
| Centre Hospitalier de Gonesse, pédiatrie | Gonesse | 95500 | France |
| CHU de Grenoble, hôpital Couple Enfant | Grenoble | 38700 | France |
| CHU de Grenoble | Grenoble | France |
| CHU de Limoges | Limoges | France |
| Hôpital Mère-Enfant | Limoges | France |
| Hôpital Edouard Herriot, hémovigilance | Lyon | 69003 | France |
| Institut d'Hématologie et d'Oncologie Pédiatrique | Lyon | 69373 | France |
| CHU Timone | Marseille | 13385 | France |
| Hôpital de la Conception, médecine interne | Marseille | 13385 | France |
| Centre Hospitalier Intercommunal André Grégoire | Montreuil | 93100 | France |
| CHU Nantes, Hôpital Hôtel Dieu | Nantes | 44093 | France |
| Hôpital Trousseau; pédiatrie générale | Paris | 75012 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Necker enfants, maladies infectieuses et tropicales | Paris | 75015 | France |
| Hôpital Necker; biothérapie | Paris | 75015 | France |
| Hôpital Necker; maladies infectieuses et tropicales | Paris | 75015 | France |
| Hôpital Robert Debré, immunologie-hématologie pédiatrique | Paris | 75935 | France |
| CHR Reims, American Memorial Hospital | Reims | 51100 | France |
| CHU Rennes, Hôpital Pontchaillou | Rennes | 35033 | France |
| CHU Rennes, hôpital Sud | Rennes | 35203 | France |
| CHU Charles Nicolle | Rouen | 76000 | France |
| CHU de Rouen - Hôpital Charles Nicolle | Rouen | 76031 | France |
| Centre Hospitalier Delafontaine, médecine interne | Saint-Denis | 93205 | France |
| Centre Hospitalier Delafontaine, pédiatrie | Saint-Denis | 93205 | France |
| CHRU Strasbourg, Hôpital de Hautepierre | Strasbourg | 67098 | France |
| CHU Toulouse; hôpital des enfants | Toulouse | 31059 | France |
| Institut Universitaire du cancer; médecine interne | Toulouse | 31059 | France |
| CHU Nancy, Brabois enfants | Vandœuvre-lès-Nancy | 54511 | France |
| CH André Rosemon | Cayenne | 97306 | French Guiana |
| CMCK | Kourou | 97387 | French Guiana |
| CH Ouest Guyanais | Saint-Laurent-du-Maroni | 97320 | French Guiana |
| Charité-Universitätsmedizin, Berlin | Berlin | Germany |
| Pädiatrie Klinikum Delmenhorst | Delmenhorst | Germany |
| Heinrich-Heine Universität Düsseldorf | Düsseldorf | Germany |
| University of Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| München | München | Germany |
| Laiko General Hospital | Athens | Greece |
| CH Basse-Terre, adultes | Basse-Terre | 97100 | Guadeloupe |
| CH Basse-Terre, enfants | Basse-Terre | 97100 | Guadeloupe |
| CHU Pointe à Pitre | Pointe-à -Pitre | 97159 | Guadeloupe |
| Clinica Pediatrica AOU | Naples | Italy |
| Azienda Ospedaliera-University of Padova | Padova | Italy |
| Azienda Ospedaliera Universitaria Integrata (AOUI Verona) | Verona | Italy |
| CHU Fort de France | Fort-de-France | 97200 | Martinique |
| Hôpital Pierre Zobda-Quitman | Fort-de-France | Martinique |
| CH Lamentin | Le Lamentin | 97232 | Martinique |
| Derived |
| de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galacteros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23. |
| COMPLETED |
|
| NOT COMPLETED |
|
1906 patients included but 1903 patient took at least one dose of Siklos and are included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Sickle Cell Disease Treated With Siklos® | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1906 patients were included but 1903 patients took at least one dose of Siklos and were included in the analysis | Median | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | 1906 patients were included but 1903 patient took at least one dose of Siklos and were included in the analysis | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | 1906 patients were included but 1903 took at least one dose of Siklos and were included in the analysis | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % of Patient-years With Malignancies | Patients with follow-up visit | Posted | Number | % patient-years | During the follow-up of participant, up to 10 years |
|
|
| |||||||||||||||||||||||||||
| Primary | % of Patient-years With Skin Ulcerations | Patients with at least one skin ulceration | Posted | Number | % patient-years | During the follow-up of participant, up to 10 years |
|
| ||||||||||||||||||||||||||||
| Primary | % of Patient-years With Myelosuppressions | Patients with at least one myelosuppression | Posted | Number | % patient-years | During the follow-up of participant, up to 10 years |
|
|
Adverse events were collected during the follow-up of participant, up to 10 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Sickle Cell Disease Treated With Siklos® | 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. | 33 | 1,903 | 705 | 1,903 | 1,308 | 1,903 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infections and infestations | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| general disorders and administration site conditions | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infections and infestations | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical director | Addmedica | +33172690186 | corinne.duguet@addmedica.com |
| Feb 18, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Male |
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| Italy |
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| France |
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| Germany |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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