A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
Sponsor: Forma Therapeutics, Inc. • ClinicalTrials.gov ID: NCT06198712
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.
Interventions
-
Etavopivat
(Drug)
Participants will receive oral tablets or granules of etavopivat once daily.
Eligibility criteria
Conditions
Locations
- The Hospital for Sick Children — Toronto, Ontario, Canada
- HCL-HOPITAL LYON SUD_Institut d'Hématologie et d'Oncologie Pédiatrique (IHOPe) — Lyon, France
- APHP - Centre de Référence des Syndromes — Paris, France
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle — Roeun, France
- KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital — Siaya, Siaya County, Kenya
- KEMRI-Walter-Reed Kericho — Kericho, Kenya
- Kombewa Clinical Research Centre — Kisumu, Kenya
- Ahero Clinical Trials Unit — Kisumu, Kenya
- American University of Beirut Medical center — Beirut, Lebanon
- Hospital Nini — Tripoli, Lebanon
- University of Nigeria Teaching Hospital (UNTH) — Ituku-Ozalla, Enugu State, Nigeria
- Lagos University Teaching Hospital, Lagos — Lagos, Nigeria
- Aminu Kano Teaching Hospital (AKTH) — Tarauni, Nigeria
- Hacettepe University pediatric hematology — Ankara, Turkey (Türkiye)
- Acıbadem Adana Hastanesi — Seyhan, Turkey (Türkiye)
- Guys and St Thomas NHS Foundation Trust / Evelina Childrens Hospital — London, United Kingdom
- King's College Hospital - Alex Mowat Research Hub — London, United Kingdom
- Manchester Royal Infirmary_1 — Manchester, United Kingdom
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record