A multicentre trial evaluating the efficacy and safety of oral decitabine-tetrahydrouridine (NDec) in patients with sickle cell disease - NN7533-4470

ovo Nordisk A/S0 sites87 target enrollmentMay 29, 2024

ConditionsSickle cell disease Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Sickle cell disease
Sponsor: ovo Nordisk A/S
Enrollment: 87
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 29, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovo Nordisk A/S

Eligibility Criteria

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

•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, Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to Six (6\) months after the last dose of trial product for patients outside US and CA randomised to HU, Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to Twelve (12\) months after the last dose of trial product for patients randomised to HU in US and CA, 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 10^9/L at visit 1, Absolute neutrophil count \=1\.5 x 10^9/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, Female who is: 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, Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to Six (6\) months after the last dose of trial product for patients on NDec/Placebo