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

NCT04707235 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2093

Last updated 2024-08-27

No results posted yet for this study

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®.

Conditions

Interventions

DRUG

Hydroxycarbamide

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

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Theravia

    lead INDUSTRY

Principal Investigators

  • Mariane de Montalembert, MD, PhD · Hospital Necker enfants malades

  • Frédéric Galactéros, MD, PhD · Henri Mondor University Hospital

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Drug
Yes

Countries

  • France
  • French Guiana
  • Germany
  • Greece
  • Guadeloupe
  • Italy
  • Martinique
  • Reunion

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707235 on ClinicalTrials.gov