Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03247218
Eligibility Criteria:
Inclusion Criteria:
* Documented symptomatic sickle cell disease (HbSS or HbS/beta thalassemia)
* Age 18 years or older (cohort 1) and 10 - 17 years old (cohort 2)
* Able and willing to provide written informed consent and to comply with the study protocol procedures Willing to use two effective methods of contraception during study treatment until 6 months after stop of study treatment. Effective contraception methods are considered oral, injectable, implantative contraceptives or intrauterine contraceptive devices combined with use of condom.
Exclusion Criteria:
* History of transfusion during last three months before Screening
* Patients with active bacterial, viral or fungal infection requiring systemic treatment
* Patients with known infection with human immunodeficiency virus (HIV) of human T cell leukemia virus 1 (HTLV-1)
* Inadequate renal function: creatinine clearance \< 30ml/min
* Inadequate liver function: NCICTC Grade 3 liver function tests (AST, ALT \> 5x upper limit of normal (ULN))
* Patients with Chronic Active Hepatitis - HCV or HBV
* History of malignancy
* Women who are pregnant or breast feeding
* Known epileptic disease and under treatment with anticonvulsive drugs
* The receipt of any investigational product within 30 days prior to this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT03247218
Study Brief:
Protocol Section:
NCT03247218