ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
- Registration Number
- NCT04707235
- Lead Sponsor
- Theravia
- Brief Summary
As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2093
- Male or female patients with symptomatic SCD,
- ≥ 2 years old,
- Treated with Siklos®,
- Having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate.
To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:
-
Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,
-
New participants with any of the following criteria:
- history of HU treatment for more than 5 years or
- prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or
- with history of leg ulcer, or
- pregnant women without interruption of Siklos® 3 months before the beginning of the pregnancy or,
- males treated with Siklos® whose partner is pregnant and without discontinuation of Siklos® 3 months before the beginning of the pregnancy.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sickle cell disease patients treated with Siklos Hydroxycarbamide -
- Primary Outcome Measures
Name Time Method Occurrence and incidence of the number of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos® 5 years Occurrence and incidence of the number of leg ulcers 5 years Occurrence and incidence of male fertility impairment 5 years Occurrence and incidence of serious unexpected AEs causally related to Siklos® 5 years
- Secondary Outcome Measures
Name Time Method Measure of quality of life with SF12 questionnaire 5 years Quality of life for adults SCD patients
Mean age of puberty 5 years Document changes in fertility status in males and females
Mean number of patients with the use of a contraception, incidence of the use of semen cryopreservation and of semen analysis performed 5 years Document changes in fertility status in males and females
Number of switch and combination with alternative treatment 5 years Frequency and reason for temporary or permanent discontinuations of Siklos® 5 years Potential barriers to the compliance to the prescription of Siklos
Incidence of the use of semen cryopreservation and of semen analysis performed 5 years Document changes in fertility status in males and females
Incidence of semen analysis performed 5 years Document changes in fertility status in males and females
Management of Siklos® during pregnancy and outcome of pregnancy following exposure at the time of conception or at any time during the pregnancy 5 years Outcome of pregnancies Following exposure to Siklos® at the time of conception (in participant and participant's partner) or at any time during the pregnancy
Trial Locations
- Locations (87)
Bordeaux Hospital Adults
🇫🇷Bordeaux, France
Bordeaux Hospital Children
🇫🇷Bordeaux, France
Tours Regional University Hospital Center Adults
🇫🇷Chambray-lès-Tours, France
Estaing Hospital Children
🇫🇷Clermont-Ferrand, France
Amiens - Picardie Hospital Adults
🇫🇷Amiens, France
Clinique de l'Europe Amiens
🇫🇷Amiens, France
Angers Hospital Adults
🇫🇷Angers, France
Amiens Picardie Hospital Children
🇫🇷Amiens, France
Angers Hospital Center Children
🇫🇷Angers, France
Robert Ballanger Hospital Adults
🇫🇷Aulnay-sous-Bois, France
Avicenne Hospital Adults
🇫🇷Bobigny, France
Robert Ballanger Hospital Children
🇫🇷Aulnay-sous-Bois, France
Jean Verdier Hospital Children
🇫🇷Bondy, France
Ambroise Paré Hospital Children
🇫🇷Boulogne-Billancourt, France
Sud Francilien Hospital Center Adults
🇫🇷Corbeil-Essonnes, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
Louis Mourier Hospital Children
🇫🇷Colombes, France
Sud Oise Public Hospital Group Adults
🇫🇷Creil, France
Henri Mondor Hospital Adults
🇫🇷Créteil, France
Intercommunal Hospital Center of Créteil Adults and Children
🇫🇷Créteil, France
Dreux Hospital Center Children
🇫🇷Dreux, France
Gonesse Hospital Children
🇫🇷Gonesse, France
Bicêtre Hospital Adults
🇫🇷Le Kremlin-Bicêtre, France
Grenoble Hospital Children
🇫🇷La Tronche, France
Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
CH du Mans
🇫🇷Le Mans, France
Jeanne De Flandre Hospital Children
🇫🇷Lille, France
Hôpital Saint-Vincent de Paul
🇫🇷Lille, France
Hôpital Mère-Enfant - CHU de Limoges
🇫🇷Limoges, France
Edouard Herriot Hospital Adults
🇫🇷Lyon, France
Timone Hospital Adults
🇫🇷Marseille, France
Meaux Hospital Center Children
🇫🇷Meaux, France
Timone Hospital Children
🇫🇷Marseille, France
Meaux Hospital Center Adults
🇫🇷Meaux, France
St Eloi Hospital Adults
🇫🇷Montpellier, France
Montpellier Hospital Children
🇫🇷Montpellier, France
Emile Muller Hospital Adults
🇫🇷Mulhouse, France
Nice Hospital Children
🇫🇷Nice, France
Nantes Hospital Children
🇫🇷Nantes, France
Nantes Hospital Adults
🇫🇷Nantes, France
Orléans Hospital Adults
🇫🇷Orléans, France
Armand Trousseau Hospital Children
🇫🇷Paris, France
Saint-Antoine Hospital Adults
🇫🇷Paris, France
Georges Pompidou European Hospital Adults
🇫🇷Paris, France
Necker Hospital Adults
🇫🇷Paris, France
Necker Hospital Children
🇫🇷Paris, France
Robert Debré Hospital Children
🇫🇷Paris, France
Centre hospitalier Perpignan
🇫🇷Perpignan, France
Poitiers Hospital Adults
🇫🇷Poitiers, France
American Hospital Children
🇫🇷Reims, France
Reims Hospital Adults
🇫🇷Reims, France
Charles Nicolle Hospital Adults
🇫🇷Rouen, France
Pontchaillou Hospital Adults
🇫🇷Rennes, France
Rouen Hospital Children
🇫🇷Rouen, France
Yves Le Foll. Hospital Center Children
🇫🇷Saint-Brieuc, France
Delafontaine Hospital Center Adults
🇫🇷Saint-Denis, France
Toulouse University Institute of cancer Adults
🇫🇷Toulouse, France
Hautepierre Hospital Children
🇫🇷Strasbourg, France
Children Hospital
🇫🇷Toulouse, France
Saint-Quentin Hospital Center Adults
🇫🇷Saint-Quentin, France
CH de Cayenne
🇬🇫Cayenne, French Guiana
Versailles Hospital Center Children
🇫🇷Versailles, France
Clocheville Regional University Hospital Center Children
🇫🇷Tours, France
Nancy Hospital Children
🇫🇷Vandoeuvre les nancy, France
Charité Hospital Children
🇩🇪Berlin, Germany
Düsseldorf Hospital Children
🇩🇪Düsseldorf, Germany
Laiko General Hospital Adults
🇬🇷Athens, Greece
Koblenz Hospital Children
🇩🇪Koblenz, Germany
Hamburg Hospital Children
🇩🇪Hamburg, Germany
Freiburg Hospital Children
🇩🇪Freiburg, Germany
Hôpital RICOU - CHU Pointe-à-Pitre Abymes
🇬🇵Pointe-à-Pitre, Guadeloupe
CHU Martinique Adults
🇲🇶Le Lamentin, Martinique
CHU Sud Réunion
🇷🇪Saint-Pierre, Réunion
Centre hospitalier de Kourou Children
🇬🇫Kourou, French Guiana
Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children
🇬🇵Pointe-à-Pitre, Guadeloupe
Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults
🇬🇫Saint-Laurent-du-Maroni, French Guiana
CHU Fort de France Children
🇲🇶Fort-de-France, Martinique
Centre Hospitalier de l'Ouest Guyanais Franck Joly Children
🇬🇫Saint-Laurent-du-Maroni, French Guiana
Padova Hospital Children
🇮🇹Padova, Italy
Verona Hospital Children
🇮🇹Verona, Italy
AUO Policlinico di Modena
🇮🇹Modena, Italy
Napoli Hospital Children
🇮🇹Napoli, Italy
Louis Mourier Hospital Adults
🇫🇷Colombes, France
Marne-La-Vallée Hospital Center Children
🇫🇷Jossigny, France
Grenoble Hospital Adults
🇫🇷La Tronche, France
Delafontaine Hospital Center Children
🇫🇷Saint-Denis, France
Hematology and oncology institute Children
🇫🇷Lyon, France