Condition: Sickle Cell Disease · Sponsor: Forma Therapeutics, Inc.
The study will test a new medicine, etavopivat, for sickle cell disease and see if it is safe and help-ful for participants with sickle cell disease who are at an increased risk of stroke. Participants will be divided into two cohorts depending on their transcranial doppler (TCD) ultrasound results and whether or not they receive hydroxyurea (medication that they may already be taking). In one cohort, participants with conditional transcranial doppler (TCD) or participants with abnormal TCD who are not able to receive hydroxyurea will be included. The study doctor will determine if the TCD result is conditional or abnormal. In another cohort, participants with conditional TCD or participants with abnormal TCD who are receiving a stable dose of hydroxyurea will be included. The study doctor will determine if the TCD result is conditional or abnormal. The participant will start a 52-week (1 year) treatment period. The participant will take 400 milligrams (mg) of etavopivat once a day for the 52 weeks. The dose of 400 mg will be taken as 2 tablets by mouth, each containing 200 mg of etavopivat. Etavopivat may be taken with or without food. Each dose should be taken with a glass of water. As part of the study, the participants will be asked to visit the clinic frequently. The participant will have the opportunity to participate in a 48-week optional extension treatment period. The optional extension treatment period will allow continued as-sessment of safety of etavopivat in paed…
This description comes directly from the study's public registry record.
Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com
Always discuss trial participation with your own doctor first.
| All India Institute of Medical Sciences (AIIMS), Raipur | Raipur, Chhattisgarh, India | Recruiting |
| All India Institute of Medical Sciences-Delhi | Delhi, India | Recruiting |
| Nirmal Hospital Pvt. Ltd. | Gujarat, India | Recruiting |
| Suretech Hospital and Research Centre Ltd. | Maharashtra, India | Recruiting |
| Indira Gandhi Government Medical College & Hospital | Nagpur, India | Not Yet Recruiting |
| University of Ibadan, University College Hospital | Ibadan, Nigeria | Recruiting |
| Lagos University Teaching Hospital, Lagos | Lagos, Nigeria | Recruiting |
| Aminu Kano Teaching Hospital (AKTH) | Tarauni, Nigeria | Recruiting |
| Sultan Qaboos University Hospital | Muscat, Sultanet of Oman/Muscat/Al Khoud, Oman | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05953584