RecruitingPhase 2NCT06198712

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

A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease


Sponsor

Forma Therapeutics, Inc.

Enrollment

95 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to learn about etavopivat, a once a day medicine taken by mouth in adolescents with sickle cell disease. The main goals are to study safety and how long etavopivat stays in the bloodstream, while also studying if there are benefits from taking etavopivat. Eligible participants who enter the study will start a 96-week treatment period. At the end of the 96 weeks, participants will have an end of study visit that occurs 4 weeks later. The participants will receive etavopivat every day throughout the treatment period.


Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Etavopivat for people with sickle cell disease. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 6 Months to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtavopivat

Participants will receive oral tablets of etavopivat once daily.


Locations(18)

The Hospital for Sick Children

Toronto, Ontario, Canada

APHP - Centre de Référence des Syndromes

Paris, France

Hospices Civils de Lyon-Hopital Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

Roeun, France

KEMRI-Walter-Reed Kericho

Kericho, Kenya

Kombewa Clinical Research Centre

Kisumu, Kenya

Ahero Clinical Trials Unit

Kisumu, Kenya

Kenya Medical Research Institute-Centre for Respiratory Disease Research, Siaya Clinical Research Annexe

Siaya, 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

View Full Details on ClinicalTrials.gov

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NCT06198712


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