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Clinical Trials in India / NCT06612268
Recruiting Phase 3

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

NCT06612268 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-02-17
Last updated
2026-09-17

Condition(s) studied

Sickle Cell Disease

Investigational drug(s) / intervention(s)

EtavopivatPlacebo

Etavopivat: Etavopivat will be administered orally.

Placebo: Placebo matching Etavopivat will be administered orally.

Study summary

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male or female. * Age 12 years or above at the time of signing the informed consent. * Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening. * Have 2-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility. * Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g/dL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 grams per litre \[g/L\]) at screening. Exclusion Criteria: * Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study. * Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study. * Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events within the previous 12 months prior to screening (i.e., an average of 1 transfusion event every 60 days). * Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment. * Receiving or use of concomitant medications that are strong or moderate inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study. * Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study. * Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy). * Hepatic dysfunction characterized by: * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or * Direct bilirubin greater than 3.0 × ULN. * Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended. * Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] at screening, calculated by the central laboratory greater than 30 mL/min/1.73 m\^ 2) or on chronic dialysis. * Travelled distance on standardized 6MWT below 100m at screening.

Primary outcome measure(s)

Trial sites (175)

FacilityCityRegionStatus
Uni of Alabama at Birmingham Birmingham Alabama Recruiting
Univer South Alabama Ped/Onc Mobile Alabama Recruiting
Phoenix Children's Hsptl Phoenix Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
Children's Hospital Los Angeles - Endocrinology Los Angeles California Recruiting
UCLA Health Los Angeles California Completed
Valley Children's Hospital Madera California Recruiting
University Of California Irvine Orange California Completed
Stanford University_Palo Alto Palo Alto California Recruiting
Harbor-UCLA Medical Center Torrance California Recruiting
Clinical and Transl Res Center Aurora Colorado Completed
Nemours/AI duPont Hosp-Chld Wilmington Delaware Recruiting
Childrens National Medical Ctr Washington D.C. District of Columbia Recruiting
MedStar Hlth Res Institute Washington D.C. District of Columbia Recruiting
Memorial Healthcare Hollywood Florida Recruiting
Children's Healthcare Atlanta Atlanta Georgia Recruiting
Childrens Hospital of Chicago Chicago Illinois Recruiting
Univer Of Illinois at Chicago Chicago Illinois Recruiting
Children's Hosp-New Orleans New Orleans Louisiana Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Henry Ford Hospital_Detroit Detroit Michigan Completed
University of Minnesota Minneapolis Minnesota Recruiting
Washington University-St.Louis St Louis Missouri Recruiting
Children's Nebraska Omaha Nebraska Recruiting
Cure 4 the Kids Foundation Las Vegas Nevada Completed
Newark Beth Israel MC Newark New Jersey Recruiting
NYC Health+Hospitals Brooklyn New York Recruiting
Interfaith Medical Center Brooklyn New York Recruiting
Northwell Health Mount Kisco New York Completed
Cohen Children's Medical Ctr Queens New York Recruiting
Jacobi Medical Center The Bronx New York Recruiting
Montefiore Medical Ctr The Bronx New York Recruiting
Duke Comprehen Sickle Cell Durham North Carolina Recruiting
Duke University Medical Center Durham North Carolina Recruiting
East Carolina Univ-Greenville Greenville North Carolina Recruiting
Atrium Health-Wake Forest Bapt Winston-Salem North Carolina Recruiting
Univ Hosp Cleveland Med Ctr Cleveland Ohio Recruiting
Ohio State Univ Wexner Med Ctr Columbus Ohio Recruiting
Univ of OK Health Sciences Ctr Oklahoma City Oklahoma Recruiting

+ 135 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06612268 on ClinicalTrials.gov ↗ ← All trials in India