A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

NCT03251482 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1083442016-004550-1564179375THR2001
• Study Type: interventional
• Target: 308
• Locations: 16 countries
• Sites: 103

Brief Summary

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death).

Conditions

VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)

  Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.

  Up to Day 10 to 14 (visit observation period)

• Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)

  Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.

  Up to Day 10 to 14 (visit observation period)

Secondary Outcomes (11)

• Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)

  Up to Day 10 to 14 (visit observation period)

• Number of Participants With Major Bleeding Event (CEC-adjudicated)

  Up to Day 10 to 14 (visit observation period)

• Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)

  Up to Day 10 to 14 (visit observation period)

• Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)

  Up to Day 10 and 14 (visit observation period)

• Number of Participants With Minimal Bleeding Events (CEC-adjudicated)

  Up to Day 10 to 14 (visit observation period)

Study Arms (11)

Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 0.3 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 0.6 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 1.2 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg

Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 A mg/kg; Drug: Apixaban placebo

Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 B mg/kg; Drug: Apixaban placebo

Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 C mg/kg; Drug: Apixaban placebo

Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo

EXPERIMENTAL

Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.

Drug: JNJ-64179375 D mg/kg; Drug: Apixaban placebo

Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg

EXPERIMENTAL

Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days.

Drug: Placebo JNJ-64179375; Drug: Apixaban 2.5 mg

Interventions

JNJ-64179375 0.3 mg/kg DRUG

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.

Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)

JNJ-64179375 0.6 mg/kg DRUG

JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.

Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)

JNJ-64179375 1.2 mg/kg DRUG

JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.

Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)

JNJ-64179375 (Dose to be Determined) DRUG

JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.

Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)

JNJ-64179375 A mg/kg DRUG

JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.

Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo

JNJ-64179375 B mg/kg DRUG

JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.

Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo

JNJ-64179375 C mg/kg DRUG

JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.

Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo

JNJ-64179375 D mg/kg DRUG

JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.

Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo

Placebo JNJ-64179375 DRUG

Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.

Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban); Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban); Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg

Apixaban placebo DRUG

Matching apixaban placebo administered orally twice a day for 10 to 14 days.

Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban); Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban); Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo; Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo; Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo; Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo

Apixaban 2.5 mg DRUG

Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.

Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban); Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban); Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban); Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban); Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight greater than or equal to (\>=) 40 kg to less than or equal to (\<=) 150 kilogram (kg)
• Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
• Has undergone an elective primary unilateral total knee replacement (TKR)
• Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
• Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

You may not qualify if:

• Any condition for which the use of apixaban is not recommended in the opinion of the investigator
• Bilateral, revision or unicompartmental procedure
• Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
• Unable to undergo venography
• Known previous deep vein thrombosis (DVT) in either lower extremity

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (103)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Denver Metro Orthopedics, PC

Englewood, Colorado, 80113, United States

Location

Florida Research Associates, LLC

DeLand, Florida, 32720, United States

Location

Avanza research

Pensacola, Florida, 32504, United States

Location

University Orthopedic and Joint Replacement Center

Tamarac, Florida, 33321, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Hospital Italiano de Buenos Aires

Caba, C1199ABB, Argentina

Location

Clínica Adventista Belgrano

CABA, C1430EGF, Argentina

Location

Hospital San Roque

Córdoba, 5000, Argentina

Location

Clínica Chutro

Córdoba, X5000EPU, Argentina

Location

Hospital Italiano La Plata

La Plata, B1900AXI, Argentina

Location

Sanatorio Britanico de Rosario

Rosario, 2000, Argentina

Location

Sanatorio San Miguel

San Miguel, B1663GFL, Argentina

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

ZNA Jan Palfijn

Merksem, 2170, Belgium

Location

Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina

Belo Horizonte, 30130-100, Brazil

Location

Hospital Sao Francisco de Assis

Belo Horizonte, 30360-290, Brazil

Location

Unicamp - Hospital de Clinicas

Campinas, 13083-888, Brazil

Location

Uniort.e - Hospital de ortopedia

Londrina, 86050-000, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Marília

Marília, 17515-000, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90020-090, Brazil

Location

Hospital e Maternidade Dr Christovão da Gama

Santo André, 09030-010, Brazil

Location

Hospital Estadual Mario covas

Santo André, 09190-615, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

São Paulo, 05403-010, Brazil

Location

Multiprofile Hospital for Active Treatment Russe

Rousse, 7002, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofa, 1407, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Lakeridge Health Ajax

Ajax, Ontario, L1S 2J4, Canada

Location

Source Trial Solutions Inc.

Kitchener, Ontario, N2M 1A1, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Cliniche Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

IRCCS Policlinico San Donato

S. Donato Milanese, 20097, Italy

Location

A.O.U. Città della Salute e della Scienza

Torino, 10126, Italy

Location

Ospedale Mauriziano (Torino)

Torino, 10128, Italy

Location

Matsudo City General Hospital

Chiba, 270-2296, Japan

Location

Hakodate Goryokaku Hospital

Hakodate, 040-8611, Japan

Location

Ritsuzankai Iida Hospital

Iida-shi, 395-8505, Japan

Location

Itami City Hospital

Itami-shi, 664-8540, Japan

Location

Yonemori Hospital

Kagoshima, 890-0062, Japan

Location

Bange Kousei General Hospital

Kawanuma-Gun, 969-6593, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, 530-0012, Japan

Location

Osaka Rosai Hospital

Osaka, 591-8025, Japan

Location

Tokushima Municipal Hospital

Tokushima, 770-0812, Japan

Location

Yuaikai Tomishiro Central Hospital

Tomishiro, 901-0243, Japan

Location

Regional Hospital of Liepaja

Liepāja, LV-3414, Latvia

Location

Riga 2nd Hospital

Riga, LV1004, Latvia

Location

Hospital of Traumatology and Orthopedics

Riga, LV1005, Latvia

Location

Vidzemes Hospital

Valmiera, LV-4201, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, LT50161, Lithuania

Location

Klaipeda University Hospital

Klaipėda, 92288, Lithuania

Location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Hospital Miri

Miri, 98000, Malaysia

Location

Hospital Sibu

Sibu, 96000, Malaysia

Location

Hospital Sultan Abdul Halim

Sungai Petani, 08000, Malaysia

Location

Klinika Ortopedii i Traumatologii UMB

Bialystok, 15-276, Poland

Location

Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela

Grajewo, 19-203, Poland

Location

Klinika Ortopedii Gornoslaskie Centrum Medyczne

Katowice, 40-635, Poland

Location

Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera

Krakow, 31-826, Poland

Location

SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny

Krakow, 33-332, Poland

Location

CSK UM Klinika Ortopedii

Lodz, 92-213, Poland

Location

Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny

Lublin, 20-718, Poland

Location

Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM

Poznan, 61-545, Poland

Location

Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika

Tarnów, 33-100, Poland

Location

Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ

Warsaw, 03-242, Poland

Location

Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement

Barnaul, 656045, Russia

Location

Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics

Kurgan, 640014, Russia

Location

Moscow City Clinical Hospital #1 n.a. N.I.Pirogov

Moscow, 117049, Russia

Location

Privolzhsky Research Medical University of Ministry of Health of Russian Federation

Nizhny Novgorod, 603155, Russia

Location

St. Petersburg State Medical Institution City Multifunctional Hospital #2

Saint Petersburg, 194354, Russia

Location

Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden

Saint Petersburg, 195427, Russia

Location

State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin

Samara, 443095, Russia

Location

Clinical Emergency Hospital n.a. N.V. Solovyev

Yaroslavl, 150003, Russia

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Univ. Fund. Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Ankara Numune Research and Training Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Dışkapı Yıldırım Beyazıd Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, 06370, Turkey (Türkiye)

Location

Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Bakirkoy Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

Izmir Tepecik Training and Research Hospital

Izmir, 35180, Turkey (Türkiye)

Location

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences

Kharkiv, 61024, Ukraine

Location

Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital'

Kharkiv, 61176, Ukraine

Location

Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'

Lviv-Vynnyky, 79495, Ukraine

Location

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnytsia, 21018, Ukraine

Location

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhia, 69600, Ukraine

Location

MeSH Terms

Interventions

apixaban

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blinded

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: November 13, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: November 25, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-11

Locations

LI (2); CA (3); BU (3); LA (4); BR (9); TU (7); UA (8); BE (4); PL (10); US (7); IT (8); AR (7); JP (10); RU (8); ES (8); MY (5)