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Etavopivat for Sickle Cell Disease

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 24, 48, and 96

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24, 48, and 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24, 48, and 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24, 48, and 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs related to etavopivat

Single-dose: area under the plasma concentration time curve from dosing (time 0) to time t ((AUC)0-t)

Single-dose: area under the plasma concentration time curve from zero to time infinity (AUC0-inf)

+5 more

Secondary outcome measures

Change from baseline in Annualized Rate of VOC

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale

Change from baseline in number of vaso-occlusive crises (VOCs)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EtavopivatExperimental Treatment1 Intervention

Participants will receive Etavopivat once daily (QD) orally.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Forma Therapeutics, Inc.Lead Sponsor

12 Previous Clinical Trials

1,199 Total Patients Enrolled

Novo Nordisk A/SIndustry Sponsor

1,514 Previous Clinical Trials

2,415,018 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

106 Previous Clinical Trials

139,776 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to enroll in this ongoing medical study?

"According to the details provided on clinicaltrials.gov, this investigation is currently in pursuit of suitable candidates. The trial was originally released for public view on February 7th, 2023 and underwent its latest revision on February 16th, 2024."

Answered by AI

What is the current number of individuals receiving medical care as part of this clinical trial?

"Indeed, details on clinicaltrials.gov imply that this research study is presently seeking volunteers. The trial was initially listed on February 7th, 2023 and last modified on February 16th, 2024. A total of 50 participants are being sought across seven designated sites."

Answered by AI

How many different medical facilities in the city are involved in conducting this clinical trial?

"At present, this research is actively enrolling participants at 7 distinct locations. These include On, Manchester, and Beirut alongside additional sites in 7 other cities. Opting for the closest site to you can help reduce travel burdens should you decide to participate."

Answered by AI

Are individuals who are older than 85 years old eligible to participate in this clinical trial?

"To be eligible for this research study, individuals aged between 12 and 18 are sought. Among the active trials, there are a total of 116 trials catering to participants under 18 years old and another 77 geared towards those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06198712.