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OpenTrials
Completed

NCT Number: NCT02516579

European Sickle Cell Disease Cohort - Hydroxyurea

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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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens - Picardie - Site sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
  • With symptomatic sickle cell syndrome
  • Treated with Siklos®
  • Having been informed of the study by the initiating physician and consenting to participate to the cohort.

Treatment and study plan

Siklos

Drug

Other names: hydrocarbamide

Primary outcomes

  1. % of Patient-years With Malignancies

    Time frame: During the follow-up of participant, up to 10 years

  2. % of Patient-years With Skin Ulcerations

    Time frame: During the follow-up of participant, up to 10 years

    Patients with at least one skin ulceration

  3. % of Patient-years With Myelosuppressions

    Time frame: During the follow-up of participant, up to 10 years

    Patients with at least one myelosuppression

Sponsors and collaborators

Lead sponsor

Theravia

Industry

Registry information

Official study title

ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

Acronym: ESCORT-HU

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2015
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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