An observational study in Sickle Cell Disease, sponsored by Theravia. Active, not recruiting at 87 sites in 8 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Theravia (part of Norgine) · Observational
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®.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's enrollment of 2,093 is above the median of 100 across 296 observational studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Theravia is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Theravia became part of Norgine.
Counted across the registry records on this site, refreshed daily.
Investigators will be recruited among physicians experienced in SCD management who are the only ones authorised to initiate Siklos® treatment hence to enrol and to follow up the participants. Investigators who are already participating in ESCORT-HU study will be asked to participate in the extension study.
Patient selection will be based on a systematic sampling technique: during the recruitment period, patients fulfilling the inclusion criteria will be informed by their initiating physician about the ESCORT-HU Extension study and enrolled in case they agree to participate.
Inclusion Criteria:
To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:
New participants with any of the following criteria:
Drug: Hydroxycarbamide
Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
Also known as: Siklos, Hydroxyurea
Occurrence and incidence of the number of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®
Time frame: 5 years
Occurrence and incidence of the number of leg ulcers
Time frame: 5 years
Occurrence and incidence of male fertility impairment
Time frame: 5 years
Occurrence and incidence of serious unexpected AEs causally related to Siklos®
Time frame: 5 years
Mean age of puberty
Document changes in fertility status in males and females
Time frame: 5 years
Mean number of patients with the use of a contraception, incidence of the use of semen cryopreservation and of semen analysis performed
Document changes in fertility status in males and females
Time frame: 5 years
Incidence of the use of semen cryopreservation and of semen analysis performed
Document changes in fertility status in males and females
Time frame: 5 years
Incidence of semen analysis performed
Document changes in fertility status in males and females
Time frame: 5 years
Management of Siklos® during pregnancy and outcome of pregnancy following exposure at the time of conception or at any time during the pregnancy
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
Time frame: 5 years
Frequency and reason for temporary or permanent discontinuations of Siklos®
Potential barriers to the compliance to the prescription of Siklos
Time frame: 5 years
Number of switch and combination with alternative treatment
Time frame: 5 years
Measure of quality of life with SF12 questionnaire
Quality of life for adults SCD patients
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2020 (actual). Primary completion is estimated for Aug 2025, 60 months after the start.
Of 139 observational studies under Anemia, Sickle Cell, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 109. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.