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Blood disorder Other

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

Locations

Canada, France, Greece, India, Italy, Lebanon, South Africa, Spain, Turkey, United Kingdom, United States

Start date

07/07/2022
Trial ID
NN7533-4470
NCT number
NCT05405114
Eudract number
2020-003485-39

Summary

This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.

Trial Overview:

Condition

Sickle Cell Disease

Treatment

Drug: NDec - oral decitabine-tetrahydrouridine

Drug: HU - Hydroxyurea

Drug: Placebo

Study type

Interventional

Trial duration

Jul 07 2022 - May 29 2025

Estimated enrollment

84

Phase

II

Are you eligible?

Gender

Male and female

Age

18 years and older

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.