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Etavopivat for Sickle Cell Disease (HIBISCUS KIDS Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Forma Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and 24
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study a new medicine called etavopivat in adolescents with sickle cell disease. The main objectives are to assess the safety, duration in the bloodstream, and potential benefits of

Who is the study for?
This trial is for adolescents with Sickle Cell Disease who've been hospitalized for related complications in the last year. They must have a stable dose of hydroxyurea or crizanlizumab, if taking them, and meet specific health criteria like hemoglobin levels and proteinuria. Those on chronic transfusion therapy or with unstable conditions are excluded.
What is being tested?
The study tests etavopivat, an oral medication taken daily by patients with sickle cell disease over a period of 96 weeks. It aims to assess the drug's safety, how long it stays in the blood, and potential benefits.
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to new medications such as digestive issues, headaches, possible allergic reactions or skin rashes. The study specifically monitors safety which suggests close tracking of any adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EtavopivatExperimental Treatment1 Intervention
Participants will receive Etavopivat once daily (QD) orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etavopivat
2024
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
1,171 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,560 Previous Clinical Trials
3,646,457 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,863 Total Patients Enrolled
~33 spots leftby Feb 2029
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