Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
4 other identifiers
interventional
289
17 countries
126
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of imetelstat sodium in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Phase 2 study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat sodium to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Phase 3 study. A separate Ventricular Repolarization Substudy (QTc Substudy) will evaluate the effect of imetelstat sodium on ventricular repolarization. An Extension Phase has been included to allow continued treatment for those participants who are benefitting from imetelstat sodium and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2016
Longer than P75 for phase_2
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedStudy Start
First participant enrolled
January 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2023
CompletedResults Posted
Study results publicly available
February 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2026
ExpectedJanuary 5, 2026
September 1, 2025
7.8 years
October 27, 2015
September 24, 2024
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase 2: Percentage of Participants Without Any Red Blood Cell (RBC) Transfusion During Any Consecutive 8-Weeks Period (All Participants)
Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
Up to 5 years in Phase 2
Phase 2: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period in Target Population
Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
Up to 5 years in Phase 2
Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period
Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
Up to 3.7 years in Phase 3
Secondary Outcomes (21)
Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
Phase 2 and Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 24-Weeks Period
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
Phase 2 and Phase 3: Time to the 8-Weeks RBC Transfusion Independence (TI)
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
Phase 2 and Phase 3: Time to the 24-Weeks RBC TI
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
Phase 2 and Phase 3: Duration of RBC TI
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
- +16 more secondary outcomes
Other Outcomes (3)
Extension Phase: Number of Participants With AEs
Up to approximately 3 years in the extension phase
Extension Phase: Overall Survival
Up to approximately 3 years in the extension phase
Extension Phase: Progression Free Survival (PFS) Survival
Up to approximately 3 years in the extension phase
Study Arms (7)
Phase 2: Imetelstat Sodium
EXPERIMENTALImetelstat sodium administered intravenously (IV), at a starting dose of 7.5 milligrams per kilogram (mg/kg), every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Imetelstat Sodium
EXPERIMENTALImetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
PLACEBO COMPARATORImetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Imetelstat Sodium
EXPERIMENTALImetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
QTc Substudy: Placebo
PLACEBO COMPARATORImetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
Extension Phase: Imetelstat Sodium
EXPERIMENTALParticipants randomized to the imetelstat sodium arm in the Phase 3 and the VR QTc Substudy, based on the response will continue to receive imetelstat sodium IV, at the dose they were receiving in the Phase 3 or VR QTc Substudy, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, study termination, or up to 3 years whichever occurs first.
Extension Phase: Extended Follow-up
EXPERIMENTALParticipants randomized to the placebo arm in the Phase 3 study will enter the Extended Follow-up part of the Extension Phase and continue in follow up until death, lost to follow-up, withdrawal of consent, study termination, or whichever occurs first up to approximately 3 years.
Interventions
Imetelstat sodium IV infusion.
Imetelstat sodium-matching placebo IV infusion.
Eligibility Criteria
You may qualify if:
- Man or woman greater than or equal to (≥) 18 years of age
- Diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Cycle 1 Day 1 (C1D1) (Phase 2) or randomization (Phase 3). In Ventricular Repolarization Substudy, diagnosis of MDS or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to C1D1
- International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
- Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to (≤) 9.0 gram per deciliter (g/dL) to count towards the 4 units total
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
You may not qualify if:
- Participant has known allergies, hypersensitivity, or intolerance to imetelstat sodium or its excipients
- Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
- Prior treatment with imetelstat sodium
- Have received corticosteroids greater than (\>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
- Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)
- Phase 3: a) Prior treatment with a hypomethylating agent (example \[eg\], azacitidine, decitabine); b) Prior treatment with lenalidomide
- Concurrent therapy with medications known to prolong the QT interval and have been associated with Torsade de pointes arrhythmia (TdP)
- Cardiac function abnormalities on screening ECG as follows:
- Resting heart rate outside of 50 to 100 beats per minute
- QT interval by Fridericia's correction method (QTcF) \>470 millisecond (msec) (or QTcF \>490 msec in the presence of a right bundle branch block or ventricular conduction delay \[QRS \>119 msec\]), determined by central assessment based on the average value of a triplicate set of ECGs
- Diagnosed or suspected congenital long QT syndrome
- Family history of sudden unexpected death from cardiac-related causes if indicative of a pathogenic mutation of cardiac ion channels
- Family history of congenital long QT syndrome
- History of Mobitz II second degree or third degree heart block
- Implantable pacemaker or automatic implantable cardioverter defibrillator
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (126)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Acrc/Arizona Clinical Research, Inc.
Tucson, Arizona, 85715, United States
CBCC Global Research, Inc.
Bakersfield, California, 93309, United States
UCLA Ronald Regan Medical Center
Los Angeles, California, 90095, United States
Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
New Haven, Connecticut, 06510-3220, United States
BRCR Medical Center
Plantation, Florida, 33326, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Franciscan Health
Indianapolis, Indiana, 46237-8601, United States
St. Agnes Healthcare, Inc
Baltimore, Maryland, 21229, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10065, United States
Cleveland Clinic Taussig Cancer
Cleveland, Ohio, 44195, United States
The Ohio State Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Prairie lakes Healthcare system, Inc
Watertown, South Dakota, 57201, United States
Vanderbilt University Medical - Hematology-Oncology
Nashville, Tennessee, 37232-6307, United States
Texas Oncology/Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
Simmons Comprehensive Cancer Center
Dallas, Texas, 75390, United States
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, 98109-1024, United States
ZAS Middelheim
Antwerp, Antwerpen, 2020, Belgium
ZAS Cadix
Antwerp, Antwerpen, 2030, Belgium
GZA Ziekenhuizen - Campus Sint
Wilrijk, Antwerpen, 2610, Belgium
AZ Sint-Jan Burgge-Oostende
Bruges, West-Vlaanderen, 8000, Belgium
Az Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
AZ Klina
Brasschaat, 2930, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
University of Alberta Hospital - Hematology Research
Edmonton, Alberta, T6G 2R3, Canada
The Ottawa Hospital
Ottawa, Ontario, K1G 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2L7, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Fakultni nemocnice Brno
Brno, Brno-město, 625 00, Czechia
FN Hradec Kralove
Hradec Králové, Hradec Králové, 500 05, Czechia
FN Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Hopital de l'Archet
Nice, Alpes-Maritimes, 6202, France
CHU Tours
Tours, Centre-Val de Loire, 37044, France
CHU de Limoges, Hopital Dupuytren
Limoges, Haute-Vienne, 87042, France
CHU de Grenoble - Hôpital Albe
La Tronche, Isère, 38700, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CH Le Mans - HAEMATOLOGY
Le Mans, Sarthe, 72037, France
CHU de Poitiers
Poitiers, Vienne, 86021, France
Centre Hospitalier Universitai
Angers, 49100, France
CHRU de Lille - Hopital Claude Huriez - Maladies du Sang
Lille, 59037, France
CHU - Hôpital Saint Louis - H
Paris, Île-de-France Region, 75010, France
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Fachärztliche Gemeinschaftspraxis mit Schwerpunkt
Dresden, Saxony, 1307, Germany
University Hospital Leipzig
Leipzig, Saxony, 4107, Germany
Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz
Aschaffenburg, 63739, Germany
University Hospital Bonn
Bonn, 53127, Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Johannes Gutenberg Universität
Mainz, 55131, Germany
The Edith Wolfson Medical Center
H̱olon, Central District, 58100, Israel
Meir Medical Center
Kfar Saba, Central District, 44281, Israel
Kaplan Medical Center
Rehovot, Hagalil Saint, 7610001, Israel
Hadassah Medical Organization
Jerusalem, Jerusalem, 9112001, Israel
Ha'Emek Medical Center
Afula, Northern District, 1834111, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, 49372, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv, 5265601, Israel
Carmel MC
Haifa, 3436212, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492, Israel
A.O. Ospedale Niguarda Ca' Granda
Milan, Lombardy, 20162, Italy
Istituto Clinico Humanitas Rozzano, IRCCS
Rozzano, Milano, 20089, Italy
Irccs Crob
Rionero in Vulture, Potenza, 85028, Italy
A.O. Universitaria Policlinico Tor Vergata
Roma, Roma, 00133, Italy
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
Ancona, 60020, Italy
AOU di Bologna Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi di Firenze
Florence, 50134, Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, 89124, Italy
AO S. Andrea, Università degli Studi di Roma La Sapienza
Roma, 189, Italy
Ospedale di Circolo, PO Varese
Varese, 21100, Italy
Radboud Umcn
Nijmegen, Gelderland, 6525 GA, Netherlands
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, Lower Silesian Voivodeship, 50-367, Poland
Wojewódzki Szpital Specjalistyczny sp.z o.o.
Słupsk, Pomeranian Voivodeship, 76-200, Poland
PRATIA Poznań
Poznan, Ul. Gryfińska 1, 60-192, Poland
SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii
Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland
Ars Medical sp. z o.o.
Piła, Wielkopolskie Województwo, 64-920, Poland
Clinics of Samarskiy GMU
Samara, Volga, 443079, Russia
Emergency Hospital of Dzerzhinsk
Dzerzhinsk, 606019, Russia
City Clinical Hospital
Moscow, 129301, Russia
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, 603126, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
FGU-Russian Research Institut
Saint Petersburg, 191024, Russia
Oncologic Dispensary No.2
Sochi, 354057, Russia
Pusan National University Hospital - Hematology and Oncology
Seogu, Incheon, 42941, South Korea
Gachon University Gil Medical Center - oncology
Incheon, Incheon Gwang'Yeogsi, 21565, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Severance Hospital, Yonsei Uni
Seoul, 3722, South Korea
H.U.Pta.del Mar
Cadiz, Cádiz, 11009, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario Doctor
Valencia, Valencia, 46017, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp. Univ. Vall D Hebron
Barcelona, 08035, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
University Hospital in Basel
Basel, Basel-Stadt (de), 4031, Switzerland
Inselspital - Universitätsspital Bern
Bern, Canton of Bern, 3010, Switzerland
Kantonsspital St. Gallen - Onkologie/Hämatologie
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Universitaetsspital Zuerich
Zurich, Canton of Zurich, 8091, Switzerland
Ankara University Medical Faculty - Hematology
Ankara, Anatolia, 6590, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi - Hematology
Izmir, İzmir, 35040, Turkey (Türkiye)
Cukurova University Medical Faculty
Adana, 1330, Turkey (Türkiye)
KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi
Cherkasy, Cherkasy Oblast, 18009, Ukraine
KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi
Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine
Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr
Lviv, Lviv Oblast, 79044, Ukraine
The Leeds Teaching Hospitals NHS Trust
Leeds, Leeds, LS9 7TF, United Kingdom
Nottingham City Hospital - Clinical Haematology
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Southampton University Hospital
Southampton, Southampton, SO16 6YD, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, AB252ZL, United Kingdom
Related Publications (3)
Kim N, Pulte ED, Ehrlich LA, Ionan AC, Haupert S, Vallejo J, Green F, Zheng N, Wang Y, Liu J, Blanco JG, Dorff SE, Booth B, Choe M, Gehrke B, Bhatnagar V, Theoret M, Pazdur R, De Claro RA, Norsworthy KJ. US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia. J Clin Oncol. 2025 Dec 10;43(35):3760-3768. doi: 10.1200/JCO-25-01369. Epub 2025 Oct 24.
PMID: 41135032DERIVEDPlatzbecker U, Santini V, Fenaux P, Sekeres MA, Savona MR, Madanat YF, Diez-Campelo M, Valcarcel D, Illmer T, Jonasova A, Belohlavkova P, Sherman LJ, Berry T, Dougherty S, Shah S, Xia Q, Sun L, Wan Y, Huang F, Ikin A, Navada S, Feller F, Komrokji RS, Zeidan AM. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jan 20;403(10423):249-260. doi: 10.1016/S0140-6736(23)01724-5. Epub 2023 Dec 1.
PMID: 38048786DERIVEDSteensma DP, Fenaux P, Van Eygen K, Raza A, Santini V, Germing U, Font P, Diez-Campelo M, Thepot S, Vellenga E, Patnaik MM, Jang JH, Varsos H, Bussolari J, Rose E, Sherman L, Sun L, Wan Y, Dougherty S, Huang F, Feller F, Rizo A, Platzbecker U. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study. J Clin Oncol. 2021 Jan 1;39(1):48-56. doi: 10.1200/JCO.20.01895. Epub 2020 Oct 27.
PMID: 33108243DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Geron Corp.
Study Officials
- STUDY DIRECTOR
Tymara Berry, MD
Geron Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
November 6, 2015
Study Start
January 12, 2016
Primary Completion
October 13, 2023
Study Completion (Estimated)
October 13, 2026
Last Updated
January 5, 2026
Results First Posted
February 14, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share