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Trial record 6 of 21 for:    sasa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04707235
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : March 25, 2022
Sponsor:
Collaborator:
International Clinical Trials Association
Information provided by (Responsible Party):
ADDMEDICA SASA

Tracking Information
First Submitted Date December 22, 2020
First Posted Date January 13, 2021
Last Update Posted Date March 25, 2022
Actual Study Start Date August 21, 2020
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2021)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 12, 2021)
  • Mean age of puberty [ Time Frame: 5 years ]
    Document changes in fertility status in males and females
  • Mean number of patients with the use of a contraception, incidence of the use of semen cryopreservation and of semen analysis performed [ Time Frame: 5 years ]
    Document changes in fertility status in males and females
  • Incidence of the use of semen cryopreservation and of semen analysis performed [ Time Frame: 5 years ]
    Document changes in fertility status in males and females
  • Incidence of semen analysis performed [ Time Frame: 5 years ]
    Document changes in fertility status in males and females
  • Management of Siklos® during pregnancy and outcome of pregnancy following exposure at the time of conception or at any time during the pregnancy [ Time Frame: 5 years ]
    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
  • Frequency and reason for temporary or permanent discontinuations of Siklos® [ Time Frame: 5 years ]
    Potential barriers to the compliance to the prescription of Siklos
  • Number of switch and combination with alternative treatment [ Time Frame: 5 years ]
  • Measure of quality of life with SF12 questionnaire [ Time Frame: 5 years ]
    Quality of life for adults SCD patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
Official Title ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
Brief 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®.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

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.

Condition Sickle Cell Disease
Intervention Drug: Hydroxycarbamide
Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
Other Names:
  • Siklos
  • Hydroxyurea
Study Groups/Cohorts Sickle cell disease patients treated with Siklos
Intervention: Drug: Hydroxycarbamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 12, 2021)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 21, 2025
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female patients with symptomatic SCD,
  • ≥ 2 years old,
  • Treated with Siklos®,
  • Having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate.

To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:

  • Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,
  • New participants with any of the following criteria:

    • history of HU treatment for more than 5 years or
    • prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or
    • with history of leg ulcer, or
    • pregnant women without interruption of Siklos® 3 months before the beginning of the pregnancy or,
    • males treated with Siklos® whose partner is pregnant and without discontinuation of Siklos® 3 months before the beginning of the pregnancy.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Corinne Duguet, MD + 33 1 72 69 01 86 corinne.duguet@addmedica.com
Contact: Laura Thomas-bourgneuf +33 1 72 69 01 86 laura.thomas-bourgneuf@addmedica.com
Listed Location Countries France,   French Guiana,   Germany,   Greece,   Guadeloupe,   Italy,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT04707235
Other Study ID Numbers ESCORT-HU Extension
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ADDMEDICA SASA
Study Sponsor ADDMEDICA SASA
Collaborators International Clinical Trials Association
Investigators
Study Chair: Mariane de Montalembert, MD, PhD Hospital Necker enfants malades
Study Chair: Frédéric Galactéros, MD, PhD Henri Mondor University Hospital
PRS Account ADDMEDICA SASA
Verification Date March 2022