LBCTR2024015480
Not yet recruiting
Phase 2
A multicentre trial evaluating the efficacy and safety of oral decitabine-tetrahydrouridine (NDec) in patients with sickle cell disease
ovo Nordisk0 sites87 target enrollmentMarch 26, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Patients with Sickle Cell Disease.
- Sponsor
- ovo Nordisk
- Enrollment
- 87
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key inclusion criteria:
- •\- Age above or equal to 18 years at the time of signing informed consent
- •\- Confirmed diagnosis of SCD (including HbSS, HbSC, HbSß0 thalassaemia and HbSß\+ thalassaemia or other Sickle Cell disease variants)
- •\- 2–10 episodes of documented VOCs within the last 12 months prior to the screening visit
- •\- Haemoglobin \=5\.0 g/dL and \=10\.5 g/dL at visit 1
- •\- Absolute reticulocyte (absolute) count above ULN at visit 1
- •\- Body weight 40 to 125 kg (inclusive)
Exclusion Criteria
- •Key exclusion criteria:
- •\- Patient is on chronic transfusion therapy as defined by receiving scheduled (pre\-planned) series of blood transfusion (simple or exchange) for prophylactic purposes, or the patient is likely to begin chronic transfusion therapy during the course of the trial, or has received RBC or whole blood transfusion for any reason within 28 days of visit 1
- •\- Receipt of erythropoietin or other haematopoietic growth factor treatment within 28 days of signing ICF, or planned treatment with these agents during the trial
- •\- Receipt of voxelotor, crizanlizumab or L\-glutamine treatment within 12 weeks of signing the informed consent form, or planned treatment with such agents during the trial
- •\- Platelet count \>800 x 109/L at visit 1
- •\- Absolute neutrophil count \=1\.5 x 109/L at visit 1
- •\- Any condition/concurrent chronic disease involving the stomach or small intestine which may affect drug absorption, as per investigator's judgement
- •\- Female who is:
- •\- pregnant, breast\-feeding or intends to become pregnant within 6 months after the final trial product administration or
- •\- child\-bearing potential and not using highly effective methods of contraception and whose male partner is not using effective contraception, at screening and until 6 months after the last dose of trial product
Outcomes
Primary Outcomes
Not specified
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