Back to resultsA Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Primary Purpose
Sickle Cell Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etavopivat Tablets Low dose
Etavopivat Tablets High dose
Placebo Tablets
Etavopivat Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Sickle Cell, Anemia, Sickle Cell Anemia, Hemolytic, Hemoglobin, Vaso-occlusive Crisis, Sickle Cell Crisis, Congenital Anemia, Hemolytic Anemia, Hematologic Disease, Hemoglobinopathies, Genetic Disease, Inborn Disease, Sickle Cell Trait, Pyruvate Kinase
Eligibility Criteria
Key Inclusion Criteria:
- Provision of consent
- Patient has a confirmed diagnosis of sickle cell disease
- At least 2 episodes of vaso-occlusive crises in the past 12 months
- Hemoglobin ≥ 5.5 and ≤ 10.5 g/dL (≥ 55 and ≤ 105 g/L) during screening
- Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
- Patients on crizanlizumab or L-glutamine treatment at the time of consent must be on a stable dose for ≥ 12 months and must be ≥ 80% compliant with the planned regimen at the time of consent and meet the VOC eligibility criteria
- Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
Key Exclusion Criteria:
- More than 10 vaso-occlusive crises within the past 12 months
- Female who is breastfeeding or pregnant
Hepatic dysfunction characterized by:
- Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
- Direct bilirubin > 3.0 × ULN
- Known HIV positivity
- Active hepatitis B or hepatitis C infection
- Severe renal dysfunction or on chronic dialysis
History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
- Unstable angina pectoris or myocardial infarction or elective coronary intervention
- Congestive heart failure requiring hospitalization
- Uncontrolled clinically significant arrhythmias
- Symptomatic pulmonary hypertension
- History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
- History of deep venous thrombosis requiring systemic anti-coagulation therapy for ≥ 6 weeks, occurring within 6 months prior to Day 1 of study treatment.
Prior/Concomitant Therapy
- Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)
- Receiving or use of concomitant medications that are strong inducers of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study
- Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study
- Use of an experimental selectin antagonist (eg, monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study
- Use of erythropoietin or other hematopoietic 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 (eg, hematopoietic cell transplant, gene modification therapy)
Sites / Locations
- University of Alabama at Birmingham (UAB)Recruiting
- Phoenix Children's HospitalRecruiting
- Woodland International Research GroupRecruiting
- University of California, IrvineRecruiting
- Collaborative Neuroscience Research, LLC.
- Pacific Research Partners, LLC
- UCSF Benioff Children's Hospital OaklandRecruiting
- UC Davis Medical Center - UC Davis Comprehensive Cancer Center - Hemotology/Oncology ClinicRecruiting
- University of Connecticut (UCONN) HealthRecruiting
- Yale UniversityRecruiting
- Children's National Health CenterRecruiting
- Howard University
- Cornerstone Research Institute
- Office of Gershwin T. Blyden, MDRecruiting
- University of Miami - Miller School of MedicineRecruiting
- Advanced Pharma CR LLC.Recruiting
- Arnold Palmer Hospital for Children - Haley Center for Children's Cancer and Blood DisordersRecruiting
- Emory University School of MedicineRecruiting
- Sonar Clinical Research
- Children's Healthcare of Atlanta - Pediatric Research CenterRecruiting
- Augusta University Center for Blood Disorders.Recruiting
- iResearch Atlanta, LLCRecruiting
- University of Illinois at Chicago Sickle Cell CenterRecruiting
- Children's Hospital New OrleansRecruiting
- University of Maryland School of MedicineRecruiting
- Boston Medical CenterRecruiting
- Barbara Ann Karmanos Cancer InstituteRecruiting
- Washington University School of Medicine Barnes - Jewish HospitalRecruiting
- University of Nebraska Medical CenterRecruiting
- Jacobi Medical CenterRecruiting
- Children's Hospital at MontefioreRecruiting
- Kings County HospitalRecruiting
- Queens Hospital CenterRecruiting
- Long Island Jewish Medical CenterRecruiting
- Columbia University Medical CenterRecruiting
- UNC School of MedicineRecruiting
- Levine Cancer InstituteRecruiting
- Duke University - Sickle Cell CenterRecruiting
- East Carolina University (ECU) PhysiciansRecruiting
- Wake Forest Baptist Medical CenterRecruiting
- University of Cincinnati Cancer CenterRecruiting
- Cincinnati Childrens Hospital Medical CenterRecruiting
- Neuro-Behavioral Clinical ResearchRecruiting
- Lynn Institute of Tulsa
- Thomas Jefferson University HospitalRecruiting
- Medical University of South Carolina (MUSC)Recruiting
- Prisma HealthRecruiting
- St. Jude Children's Research Hospital (SJCRH)Recruiting
- Methodist University HospitalRecruiting
- Baylor College of Medicine
- The University of Texas Health Science Center at HoustonRecruiting
- Mary Bridge Children's Health CenterRecruiting
- Blood Center of Wisconsin (BCW)Recruiting
- Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-JustineRecruiting
- The Hospital for Sick ChildrenRecruiting
- Providence HematologyRecruiting
- CHU Montpellier, Hôpital Saint-EloiRecruiting
- Hôpital Henri MondorRecruiting
- Hôpital Edouard HERRIOTRecruiting
- Hôpital Emile MullerRecruiting
- CHU Paris - Hôpital Robert DebréRecruiting
- Universitätsklinikum FreiburgRecruiting
- University Hospital of HeidelbergRecruiting
- General University Hospital of PatrasRecruiting
- Hippocratio General HospitalRecruiting
- General University Hospital of LarissaRecruiting
- General Hospital of Thessaloniki "Hippokration"Recruiting
- Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"Recruiting
- Azienda Ospedaliera Universitaria San Luigi GonzagaRecruiting
- Azienda Ospedale Università PadovaRecruiting
- Fondazione IRCCS Policlinico San MatteoRecruiting
- American University of Beirut Medical CenterRecruiting
- Nini HospitalRecruiting
- Sultan Qaboos University HospitalRecruiting
- Sultan Qaboos University HospitalRecruiting
- Hospital De CrucesRecruiting
- Hospital Universitari Vall d'Hebron de BarcelonaRecruiting
- Hospital Clínico San CarlosRecruiting
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La PazRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Leicester Royal Infirmary
- Guy's and St Thomas' NHS Foundation TrustRecruiting
- King's College HospitalRecruiting
- Hammersmith Hospital - Imperial College Healthcare NHS TrustRecruiting
- Imperial College Healthcare NHS Trust - St Mary's HospitalRecruiting
- Oxford University Hospitals NHS Trust - Churchill Hospital - Cancer and Haematology CentreRecruiting
- The Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Double blind etavopivat Low Dose
Double blind etavopivat High Dose
Double blind placebo
Open label etavopivat
Arm Description
Double blind etavopivat Low Dose
Double blind etavopivat High Dose
Double blind placebo
Open label etavopivat
Outcomes
Primary Outcome Measures
Hemoglobin response rate
Hemoglobin response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period
Annualized vaso-occlusive crisis
Annualized vaso-occlusive crisis rate during the 52-week blinded treatment period based on adjudicated vaso-occlusive crisis review
Secondary Outcome Measures
Hemoglobin
Change from baseline in hemoglobin at Week 24 during the blinded treatment period
Hemoglobin
Change from baseline in hemoglobin at Week 52 during the blinded treatment period
Absolute reticulocyte count
Change in absolute reticulocyte count from baseline at Week 24 during the blinded treatment period
Unconjugated bilirubin
Change in unconjugated bilirubin from baseline at Week 24 during the blinded treatment period
Lactate dehydrogenase
Change in lactate dehydrogenase from baseline at Week 24 during the blinded treatment period
Vaso-occlusive crisis
Time to first vaso-occlusive crisis during the blinded treatment period
Patient-Reported Outcome Measurement Information System (PROMIS)
Change in PROMIS Fatigue Scale from baseline in adult patients at Week 24 during the blinded treatment period
Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale
Change in PROMIS Fatigue Scale from baseline in adult patients at Week 52 during the blinded treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04624659
Brief Title
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Official Title
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).
Detailed Description
Etavopivat is designed to activate PKR and thereby modulate RBC metabolism by impacting two critical pathways in RBCs. The etavopivat clinical development program will investigate whether decreasing 2,3-DPG may help oxygen bind to hemoglobin (i.e. increasing oxygen affinity), and thereby increase ATP and impact RBC function. This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients age 12 to 65 years (inclusive), with sickle cell disease. There are two planned interim analyses in this study design. Initially, patients will be randomized at 1:1:1 to one of two dose levels of etavopivat or placebo. At the first interim analysis, one of the two etavopivat dose levels will be selected for the Phase 3 portion of the study, in which patients will be randomized at 1:1 to the selected etavopivat dose or placebo. Efficacy on hemoglobin will be evaluated at the second interim analysis, and then will be tested along with evaluation of efficacy on vaso-occlusive crises at the final analysis. Following completion of 52 weeks of double-blind treatment, patients may enter a 52-week etavopivat open-label extension period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Disease, Sickle Cell, Anemia, Sickle Cell Anemia, Hemolytic, Hemoglobin, Vaso-occlusive Crisis, Sickle Cell Crisis, Congenital Anemia, Hemolytic Anemia, Hematologic Disease, Hemoglobinopathies, Genetic Disease, Inborn Disease, Sickle Cell Trait, Pyruvate Kinase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double blind etavopivat Low Dose
Arm Type
Experimental
Arm Description
Double blind etavopivat Low Dose
Arm Title
Double blind etavopivat High Dose
Arm Type
Experimental
Arm Description
Double blind etavopivat High Dose
Arm Title
Double blind placebo
Arm Type
Experimental
Arm Description
Double blind placebo
Arm Title
Open label etavopivat
Arm Type
Experimental
Arm Description
Open label etavopivat
Intervention Type
Drug
Intervention Name(s)
Etavopivat Tablets Low dose
Other Intervention Name(s)
FT-4202
Intervention Description
200 mg once daily
Intervention Type
Drug
Intervention Name(s)
Etavopivat Tablets High dose
Other Intervention Name(s)
FT-4202
Intervention Description
400 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Other Intervention Name(s)
placebo
Intervention Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Etavopivat Tablets
Other Intervention Name(s)
FT-4202
Intervention Description
Selected dose once daily
Primary Outcome Measure Information:
Title
Hemoglobin response rate
Description
Hemoglobin response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period
Time Frame
24 Weeks
Title
Annualized vaso-occlusive crisis
Description
Annualized vaso-occlusive crisis rate during the 52-week blinded treatment period based on adjudicated vaso-occlusive crisis review
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
Change from baseline in hemoglobin at Week 24 during the blinded treatment period
Time Frame
24 Weeks
Title
Hemoglobin
Description
Change from baseline in hemoglobin at Week 52 during the blinded treatment period
Time Frame
52 Weeks
Title
Absolute reticulocyte count
Description
Change in absolute reticulocyte count from baseline at Week 24 during the blinded treatment period
Time Frame
24 Weeks
Title
Unconjugated bilirubin
Description
Change in unconjugated bilirubin from baseline at Week 24 during the blinded treatment period
Time Frame
24 Weeks
Title
Lactate dehydrogenase
Description
Change in lactate dehydrogenase from baseline at Week 24 during the blinded treatment period
Time Frame
24 Weeks
Title
Vaso-occlusive crisis
Description
Time to first vaso-occlusive crisis during the blinded treatment period
Time Frame
52 Weeks
Title
Patient-Reported Outcome Measurement Information System (PROMIS)
Description
Change in PROMIS Fatigue Scale from baseline in adult patients at Week 24 during the blinded treatment period
Time Frame
24 Weeks
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale
Description
Change in PROMIS Fatigue Scale from baseline in adult patients at Week 52 during the blinded treatment period
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Provision of consent
Patient has a confirmed diagnosis of sickle cell disease
At least 2 episodes of vaso-occlusive crises in the past 12 months
Hemoglobin ≥ 5.5 and ≤ 10.5 g/dL (≥ 55 and ≤ 105 g/L) during screening
Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
Patients on crizanlizumab or L-glutamine treatment at the time of consent must be on a stable dose for ≥ 12 months and must be ≥ 80% compliant with the planned regimen at the time of consent and meet the VOC eligibility criteria
Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
Key Exclusion Criteria:
More than 10 vaso-occlusive crises within the past 12 months
Female who is breastfeeding or pregnant
Hepatic dysfunction characterized by:
Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
Direct bilirubin > 3.0 × ULN
Known HIV positivity
Active hepatitis B or hepatitis C infection
Severe renal dysfunction or on chronic dialysis
History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
Unstable angina pectoris or myocardial infarction or elective coronary intervention
Congestive heart failure requiring hospitalization
Uncontrolled clinically significant arrhythmias
Symptomatic pulmonary hypertension
History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
History of deep venous thrombosis requiring systemic anti-coagulation therapy for ≥ 6 weeks, occurring within 6 months prior to Day 1 of study treatment.
Prior/Concomitant Therapy
Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)
Receiving or use of concomitant medications that are strong inducers of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study
Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study
Use of an experimental selectin antagonist (eg, monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study
Use of erythropoietin or other hematopoietic 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 (eg, hematopoietic cell transplant, gene modification therapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vandy Black, MD
Phone
857-209-2236
Email
medicalinformation@formatherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandy Black, MD
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Warner
Phone
205-996-5530
Email
ewarner@uabmc.edu
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Sieber
Phone
602-933-7007
Email
esieber@phoenixchildrens.com
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tandi Ilsom
Phone
501-221-8681
Email
tilsom@ergclinical.com
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Hernandez
Phone
714-456-5155
Email
nghernan@hs.uci.edu
Facility Name
Collaborative Neuroscience Research, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Terminated
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Individual Site Status
Terminated
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Decaris
Phone
510-428-3372
Email
Julie.Decaris@ucsf.edu
Facility Name
UC Davis Medical Center - UC Davis Comprehensive Cancer Center - Hemotology/Oncology Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Lopez Aguirre
Phone
916-734-6606
Email
alalopez@ucdavis.edu
Facility Name
University of Connecticut (UCONN) Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Green
Phone
860-679-8199
Email
zgreen@uchc.edu
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Huie
Phone
475-434-7881
Email
Sharon.Huie@yale.edu
Facility Name
Children's National Health Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regine Hyppolite
Phone
202-476-8081
Email
rhyppolite@childrensnational.org
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Terminated
Facility Name
Cornerstone Research Institute
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Individual Site Status
Terminated
Facility Name
Office of Gershwin T. Blyden, MD
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanetta Bronte-Hall
Phone
954-397-3251
Email
LBronte@fscdr.org
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
033136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla Haakenson
Email
pih7@med.miami.edu
Facility Name
Advanced Pharma CR LLC.
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anadelis Perez
Phone
305-220-2727
Ext
805
Email
aperez@advancedpharmacr.com
Facility Name
Arnold Palmer Hospital for Children - Haley Center for Children's Cancer and Blood Disorders
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Parker
Phone
321-841-8588
Email
Melanie.parker@orlandohealth.com
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neli Stoyanova Stoyanova
Phone
404-727-0710
Email
Neli.stoyanova@emory.edu
Facility Name
Sonar Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's Healthcare of Atlanta - Pediatric Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Ako
Phone
404-785-8863
Email
Michele-Corinne.Ako@choa.org
Facility Name
Augusta University Center for Blood Disorders.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latanya Bowman
Phone
760-721-2273
Email
lbowman@augusta.edu
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terp Vairin
Phone
404-537-1281
Email
Terp.vairin@iresearchatlanta.com
Facility Name
University of Illinois at Chicago Sickle Cell Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lani Krauz
Phone
312-996-7714
Email
lignacio@uic.edu
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Meyers
Phone
504-894-5377
Email
margaret.meyers@LCMChealth.org
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Hairrell
Phone
410-328-7611
Email
Deanna.Hairrell@umm.edu
First Name & Middle Initial & Last Name & Degree
Esther Kim
Phone
410-328-7611
Email
estherkim@umm.edu
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Pottier
Phone
617-638-7480
Email
elizabeth.pottier@bmc.org
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Tolksdorf
Phone
313-576-8673
Email
tolksdoe@karmanos.org
First Name & Middle Initial & Last Name & Degree
Carmen Rush
Phone
313-576-8730
Email
rushc@karmanos.org
Facility Name
Washington University School of Medicine Barnes - Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Thoelke
Phone
314-362-7961
Email
terin@wustl.edu
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Tran
Phone
402-559-3848
Email
alexandra.tran@unmc.edu
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabahete Zeqiraj
Phone
718-918-4284
Email
zeqirajs@nychhc.org
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Ireland
Phone
718-741-2342
Email
kireland@montefiore.org
Facility Name
Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhatra Limbu
Phone
718-245-3131
Email
limbus@nychhc.org
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Bulone
Phone
718-883-3000
Email
bulonel@nychhc.org
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicha Paul
Phone
718-470-3460
Email
Apaul14@northwell.edu
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Manrique
Phone
212-305-5371
Email
Dm3489@cumc.columbia.edu
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wichlan
Phone
919-966-2898
Email
dwichlan@med.unc.edu
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Mills
Phone
980-442-5241
Email
rachel.mills@atriumhealth.org
Facility Name
Duke University - Sickle Cell Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Muller
Phone
919-684-5378
Email
lindsey.muller@duke.edu
Facility Name
East Carolina University (ECU) Physicians
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Corbett
Phone
252-744-5437
Email
corbettl@ecu.edu
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Kern
Phone
336-713-7237
Email
Maggie.kern@atriumhealth.org
Facility Name
University of Cincinnati Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meher Swathi Devarao
Phone
513-558-2119
Email
devarams@ucmail.uc.edu
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Shova
Phone
513-636-4200
Email
Amy.Shova@cchmc.org
Facility Name
Neuro-Behavioral Clinical Research
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Boyce
Phone
330-493-1118
Email
lboyce@nb-cr.com
First Name & Middle Initial & Last Name & Degree
Greg Ingram
Phone
330-493-1118
Email
gingram@nb-cr.com
Facility Name
Lynn Institute of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Terminated
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Gallagher
Phone
215-503-5692
Email
Barbara.gallagher@jefferson.edu
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Wozniak
Phone
843-792-3188
Email
wozniakl@musc.edu
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tranaka Fuqua
Phone
543-720-5665
Email
tranaka.fuqua@prismahealth.org
Facility Name
St. Jude Children's Research Hospital (SJCRH)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia McGregor
Phone
901-595-6411
Email
olivia.mcgregor@stjude.org
Facility Name
Methodist University Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kammie Patillo
Phone
901-448-2813
Email
kgray34@uthsc.edu
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Dinu
Phone
832-824-4825
Email
brdinu@texaschildrens.org
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eyuel Baherey
Phone
713-704-7100
Email
eyuel.l.baherey@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Olatunde Oladipupo
Phone
713-704-7100
Email
Olatunde.A.Oladipupo@uth.tmc.edu
Facility Name
Mary Bridge Children's Health Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne Pugh
Phone
253-403-4613
Email
jmpugh@multicare.org
Facility Name
Blood Center of Wisconsin (BCW)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Swistara
Phone
414-937-6577
Email
gswistara@versiti.org
Facility Name
Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine
City
Montréal
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Leblanc
Phone
514-345-4931
Email
guillaume.leblanc.hsj@ssss.gouv.qc.ca
Facility Name
The Hospital for Sick Children
City
Toronto
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Merelles-Pulcini
Phone
1-416-813-5643
Email
manuela.merelles-pulcini@sickkids.ca
Facility Name
Providence Hematology
City
Vancouver
ZIP/Postal Code
V6Z 2A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Lee
Phone
604-806-9656
Email
ylee22@providencehealth.bc.ca
Facility Name
CHU Montpellier, Hôpital Saint-Eloi
City
Montpellier
State/Province
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Rousseau
Phone
+33 4 67 33 58 53
Email
f-rousseau@chu-montpellier.fr
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Djoumad
Phone
33 1 49 81 24 41
Email
sabrina.djoumad@aphp.fr
Facility Name
Hôpital Edouard HERRIOT
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Brun
Phone
+33 4 72 11 03 41
Email
dominique.brun01@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Nabil Berkane
Email
nabil.berkane@chu-lyon.fr
Facility Name
Hôpital Emile Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Haby
Phone
+ 33 (0)389647743
Email
habyc@ghrmsa.fr
Facility Name
CHU Paris - Hôpital Robert Debré
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Ouamdi
Phone
+33 1 85 55 27 74
Email
sabrina.ouamdi@aphp.fr
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ina Miessmer
Phone
0049 761 270-46950
Email
ina.miessmer@uniklinik-freiburg.de
Facility Name
University Hospital of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donate Jakoby
Phone
+49 6221 564002
Email
donate.jakoby@med.uni-heidelberg.de
Facility Name
General University Hospital of Patras
City
Rio
State/Province
Patras
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasiliki Zafeiropoulou
Phone
302613604165
Email
vickzafirop@gmail.com
Facility Name
Hippocratio General Hospital
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasia Kapota
Phone
306978096677
Email
nancy85kap@yahoo.gr
Facility Name
General University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Oikonomou
Phone
306977468625
Email
georgia.ikonomou@gmail.com
Facility Name
General Hospital of Thessaloniki "Hippokration"
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioanna Christodoulou
Phone
306972000573
Email
g.christod78@gmail.com
Facility Name
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piera Samperi
Phone
39 095 3781447
Email
psamperi@unict.it
Facility Name
Azienda Ospedaliera Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Perrone, Dr.
Phone
+39 011 9026852
Email
silvia.perrone@unito.it
Facility Name
Azienda Ospedale Università Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Paratella, Dr.
Phone
+39 049 8211490
Email
alessandra.paratella@aopd.veneto.it
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurene Kelly
Phone
39 0382 501251
Email
l.kelly@smatteo.pv.it
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghina Siblany
Phone
961 1 350 000
Ext
5595
Email
gs57@aub.edu.lb
Facility Name
Nini Hospital
City
Tripoli
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamleh Ibrahim
Phone
961 70 500 375
Email
kamleh.ibrahim@hopitalnini.com
Facility Name
Sultan Qaboos University Hospital
City
Muscat
ZIP/Postal Code
123
Country
Oman
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghalib Al Khadouri
Phone
(+968)92954729
Email
ghalibsa@squ.edu.om
Facility Name
Sultan Qaboos University Hospital
City
Muscat
ZIP/Postal Code
123
Country
Oman
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taimoora Al-Subhi
Phone
00968 96777825
Email
taimoora05@gmail.com
Facility Name
Hospital De Cruces
City
Barakaldo
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saioa Arambarri
Phone
34677380668
Email
saioa.arambarriurunuela@osakidetza.eus
Facility Name
Hospital Universitari Vall d'Hebron de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlota Aguilera
Phone
+34 934 89 30 00
Email
carlota.aguilera@vhir.org
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Santos
Phone
34 913 303 312
Email
ssantossuarez@salud.madrid.org
Facility Name
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Rojo
Phone
34 91 497 2418
Email
laurarojohematologia@gmail.com
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Barrial
Phone
34955013277
Email
luciabarrialhuvr@gmail.com
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prematie Andreou
Phone
+44 (0) 116 2586968
Email
prematie.andreou@uhl-tr.nhs.uk
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE18 3RA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chienye Asinobi
Phone
+44 (0) 2071881425
Email
chienye.asinobi@gstt.nhs.uk
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia Mercone
Phone
+44 (0) 2078365454
Email
k.mercone@nhs.net
Facility Name
Hammersmith Hospital - Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Billy Hopkins
Phone
+44 (0) 2033131175
Email
billy.hopkins@nhs.net
First Name & Middle Initial & Last Name & Degree
Nahid Shaikh
Phone
+44 (0) 203 3131175
Email
nahid.shaikh@nhs.net
Facility Name
Imperial College Healthcare NHS Trust - St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhana Ahmed
Phone
+44 (0) 203 312 6948
Email
farhana.ahmed3@nhs.net
First Name & Middle Initial & Last Name & Degree
Amina Mehar
Phone
+44 (0) 203 312 6948
Email
amina.mehar@nhs.net
Facility Name
Oxford University Hospitals NHS Trust - Churchill Hospital - Cancer and Haematology Centre
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samiya Mahmood
Phone
44 (0) 1865 226754
Email
samiya.mahmood@ouh.nhs.uk
Facility Name
The Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bones
Phone
+44 114 2713339
Email
michael.bones1@nhs.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
35019238
Citation
Forsyth S, Schroeder P, Geib J, Vrishabhendra L, Konstantinidis DG, LaSalvia K, Ribadeneira MD, Wu E, Kelly P, Kalfa TA. Safety, Pharmacokinetics, and Pharmacodynamics of Etavopivat (FT-4202), an Allosteric Activator of Pyruvate Kinase-R, in Healthy Adults: A Randomized, Placebo-Controlled, Double-Blind, First-in-Human Phase 1 Trial. Clin Pharmacol Drug Dev. 2022 May;11(5):654-665. doi: 10.1002/cpdd.1058. Epub 2022 Jan 12.
Results Reference
derived
Learn more about this trial
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
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