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European Sickle Cell Disease Cohort - Hydroxyurea

NCT02516579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1906

Last updated 2020-03-19

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Siklos

Sponsors & Collaborators

  • Theravia

    lead INDUSTRY

Principal Investigators

  • Frédéric Galacteros, MD · Hôpital henri Mondor (Adults)

  • Mariane de Montalembert, MD · Hôpital Necker Enfants Malades (Children)

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2019-03-20
Completion
2019-03-20

Countries

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

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 NCT02516579 on ClinicalTrials.gov