Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04707235

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

Sponsor: Theravia

View on ClinicalTrials.gov

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®.

Official title: ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2093

Start Date

2020-08-21

Completion Date

2025-08-21

Last Updated

2024-08-27

Healthy Volunteers

No

Interventions

DRUG

Hydroxycarbamide

Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.

Locations (87)

Amiens - Picardie Hospital Adults

Amiens, France

Amiens Picardie Hospital Children

Amiens, France

Clinique de l'Europe Amiens

Amiens, France

Angers Hospital Adults

Angers, France

Angers Hospital Center Children

Angers, France

Robert Ballanger Hospital Adults

Aulnay-sous-Bois, France

Robert Ballanger Hospital Children

Aulnay-sous-Bois, France

Avicenne Hospital Adults

Bobigny, France

Jean Verdier Hospital Children

Bondy, France

Bordeaux Hospital Adults

Bordeaux, France

Bordeaux Hospital Children

Bordeaux, France

Ambroise Paré Hospital Children

Boulogne-Billancourt, France

Tours Regional University Hospital Center Adults

Chambray-lès-Tours, France

Estaing Hospital Children

Clermont-Ferrand, France

Louis Mourier Hospital Adults

Colombes, France

Louis Mourier Hospital Children

Colombes, France

Sud Francilien Hospital Center Adults

Corbeil-Essonnes, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 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

Marne-La-Vallée Hospital Center Children

Jossigny, France

Grenoble Hospital Adults

La Tronche, France

Grenoble Hospital Children

La Tronche, France

Bicêtre Hospital Adults

Le Kremlin-Bicêtre, 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

Hematology and oncology institute Children

Lyon, France

Timone Hospital Adults

Marseille, France

Timone Hospital Children

Marseille, France

Meaux Hospital Center Adults

Meaux, France

Meaux Hospital Center Children

Meaux, France

St Eloi Hospital Adults

Montpellier, France

Montpellier Hospital Children

Montpellier, France

Emile Muller Hospital Adults

Mulhouse, France

Nantes Hospital Children

Nantes, France

Nantes Hospital Adults

Nantes, France

Nice Hospital Children

Nice, 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

Pontchaillou Hospital Adults

Rennes, France

Charles Nicolle Hospital Adults

Rouen, France

Rouen Hospital Children

Rouen, France

Yves Le Foll. Hospital Center Children

Saint-Brieuc, France

Delafontaine Hospital Center Adults

Saint-Denis, France

Delafontaine Hospital Center Children

Saint-Denis, France

Saint-Quentin Hospital Center Adults

Saint-Quentin, France

Hautepierre Hospital Children

Strasbourg, France

Children Hospital

Toulouse, France

Toulouse University Institute of cancer Adults

Toulouse, France

Clocheville Regional University Hospital Center Children

Tours, France

Nancy Hospital Children

Vandœuvre-lès-Nancy, France

Versailles Hospital Center Children

Versailles, France

CH de Cayenne

Cayenne, French Guiana

Centre hospitalier de Kourou Children

Kourou, French Guiana

Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults

Saint-Laurent-du-Maroni, French Guiana

Centre Hospitalier de l'Ouest Guyanais Franck Joly Children

Saint-Laurent-du-Maroni, French Guiana

Charité Hospital Children

Berlin, Germany

Düsseldorf Hospital Children

Düsseldorf, Germany

Freiburg Hospital Children

Freiburg im Breisgau, Germany

Hamburg Hospital Children

Hamburg, Germany

Koblenz Hospital Children

Koblenz, Germany

Laiko General Hospital Adults

Athens, Greece

Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children

Pointe-à-Pitre, Guadeloupe

Hôpital RICOU - CHU Pointe-à-Pitre Abymes

Pointe-à-Pitre, Guadeloupe

AUO Policlinico di Modena

Modena, Italy

Napoli Hospital Children

Naples, Italy

Padova Hospital Children

Padova, Italy

Verona Hospital Children

Verona, Italy

CHU Fort de France Children

Fort-de-France, Martinique

CHU Martinique Adults

Le Lamentin, Martinique

CHU Sud Réunion

Saint-Pierre, Reunion