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Small Molecule

Etavopivat for Sickle Cell Disease

Phase 2 & 3

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

Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment

At least 2 episodes of vaso-occlusive crises in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial will study whether etavopivat is effective in improving hemoglobin levels and reducing vaso-occlusive crises.

Who is the study for?

This trial is for adults and adolescents with sickle cell disease who have had at least 2 pain crises in the past year. They must be on a stable dose of certain medications, not pregnant or breastfeeding, without severe liver, kidney, heart or blood vessel problems. Participants need to use effective contraception.Check my eligibility

What is being tested?

The study tests low and high doses of Etavopivat tablets against placebo tablets to see if they can increase hemoglobin levels and reduce pain crises caused by blocked blood vessels in patients with sickle cell disease.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to altering hemoglobin function and typical drug-related side effects such as digestive issues, headaches, fatigue or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of hydroxyurea for at least 90 days.

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I have had at least 2 pain crises due to sickle cell in the last year.

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I have been diagnosed with sickle cell disease.

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I'm sorry, I cannot summarize the screening criterion as it is incomplete. Please provide more information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Annualized vaso-occlusive crisis

Hemoglobin response rate

Secondary outcome measures

Absolute reticulocyte count

Hemoglobin

Lactate dehydrogenase

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Open label etavopivatExperimental Treatment1 Intervention

Open label etavopivat

Group II: Double blind placeboExperimental Treatment1 Intervention

Double blind placebo

Group III: Double blind etavopivat Low DoseExperimental Treatment2 Interventions

Double blind etavopivat Low Dose

Group IV: Double blind etavopivat High DoseExperimental Treatment2 Interventions

Double blind etavopivat High Dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Tablets

2014

Completed Phase 4

~7210

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor

1,514 Previous Clinical Trials

2,414,724 Total Patients Enrolled

Forma Therapeutics, Inc.Lead Sponsor

12 Previous Clinical Trials

905 Total Patients Enrolled

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

106 Previous Clinical Trials

139,482 Total Patients Enrolled

Media Library

Etavopivat (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04624659 — Phase 2 & 3

Frequently Asked Questions

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

How many patients are enrolled in this trial to test the new treatment?

"In total, this study will require 344 patients that meet the inclusion criteria. Forma Therapeutics, Inc. is sponsoring the trial from different locations, such as Long Island Jewish Medical Center and UNC School of Medicine."

Answered by AI

Are there any inclusion or exclusion criteria for this experiment?

"This clinical trial is looking for 344 participants aged 12-65 who have been diagnosed with sickle cell anemia. Candidates must meet the following criteria:- Provision of consent- Hemoglobin levels between 55-105 g/L during screening- Patients taking hydroxyurea must demonstrate a stable dose for at least 90 days prior to study treatment- Patients on crizanlizumab or L-glutamine treatment must be on a stable dose for ≥ 12 months, be ≥ 80% compliant with the planned regimen, and meet the VOC eligibility criteria- Female patients of childbearing"

Answered by AI

Does this research project accept participants who are below the age of 25?

"The age requirement for this particular clinical trial is 12 to 65, which falls in the middle range of all available trials. Out of the 217 other trials, 132 are for patients younger than you, and 85 are for patients who are older."

Answered by AI

Are new patients still being accepted for this trial?

"This trial, which was originally posted on March 26th, 2021, is still recruiting patients according to the latest update on October 11th, 2022."

Answered by AI

At how many research facilities is this investigation being conducted?

"The study's clinical trial locations include Long Island Jewish Medical Center, UNC School of Medicine, Wake Forest Baptist Medical Center, and 48 other hospitals."

Answered by AI