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NCT06198712 · ClinicalTrials.gov record · last posted 2026-08-12

A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease

Study acronym: HIBISCUS KIDS
StatusRecruiting
PhasePhase 2
Started2023-01-12
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-13
Trial arms changed: 1 → 4
2026-04-25
Enrollment increased: 50 → 95 participants
Trial Details
NCT Number NCT06198712
Lead Sponsor Forma Therapeutics, Inc.
Collaborators: Novo Nordisk A/S. This study is currently undergoing a sponsor transition from Forma Therapeutics, Inc. to Novo Nordisk A/S.
Conditions Sickle Cell Disease
Enrollment 95 participants
Start Date 2023-01-12
Primary Completion 2028-02-23 (estimated)
Study Completion 2029-08-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-12