Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
2 other identifiers
interventional
199
20 countries
84
Brief Summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Longer than P75 for phase_3
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
August 1, 2024
6.8 years
June 8, 2016
August 15, 2024
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Baseline, Day 28 (± 2 days)
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Baseline, Day 28 (± 2 days)
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Baseline, Day 28 (± 2 days)
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Baseline, Day 28 (± 2 days)
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
Baseline, Day 28 (± 2 days)
Secondary Outcomes (24)
Clinical Response at 48-72 Hours
Baseline, 48-72 hours
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Baseline, Day 14 (± 2 Days)
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Baseline, Day 14 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Baseline, Day 28 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Baseline, Day 28 (± 2 Days)
- +19 more secondary outcomes
Study Arms (3)
Dalbavancin single-dose
EXPERIMENTALParticipants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
Dalbavancin two-dose
EXPERIMENTALParticipants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
Comparator
ACTIVE COMPARATORParticipants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
Interventions
Dalbavancin was administered intravenously over 30 (± 5) minutes.
Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Eligibility Criteria
You may qualify if:
- Male or female patients birth to 17 years (inclusive)
- A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
- In addition to local signs of ABSSSI, the patient has at least one of the following:
- Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
- Leukocytosis (WBC \> 10,000 mm3) or leukopenia (WBC \< 2,000 mm3) or left shift of \>10% band neutrophils
- Infection either involving deeper soft tissue or requiring significant surgical intervention
- Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration
- Male or female patients from birth to \< 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
- A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.
- Suspected or confirmed sepsis including any of the following clinical criteria:
- Hypothermia (\<36°C) OR fever (\>38.5°C)
- Bradycardia OR tachycardia OR rhythm instability
- Hypotension OR mottled skin OR impaired peripheral perfusion
- Petechial rash
- New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
- +18 more criteria
You may not qualify if:
- Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to \< 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output \< 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
- Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Patients with sustained shock defined as systolic blood pressure \< 90 mm Hg in children ≥ 10 years old, \< 70 mm Hg + \[2 x age in years\] in children 1 to \<10 years, or \< 70 mmHg in infants 3 to \<12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
- More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
- Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
- Patients with necrotizing fasciitis, or deep-seated infections that would require \> 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
- Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
- Venous catheter entry site infection.
- Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
- Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
- Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
- Patients whose skin infection is the result of having sustained full or partial thickness burns.
- Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to \< 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy.
- Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (84)
University of South Alabama /ID# 237446
Mobile, Alabama, 36604-3302, United States
Valleywise Health Medical Center /ID# 234343
Phoenix, Arizona, 85008-4973, United States
Southbay Pharma Research /ID# 235700
La Palma, California, 90623, United States
University of California, Los Angeles /ID# 237533
Los Angeles, California, 90095, United States
Duplicate_Children's Hospital Colorado /ID# 237622
Aurora, Colorado, 80045, United States
Global Research Holdings LLC /ID# 235747
Panama City, Florida, 32405, United States
Tampa General Hospital /ID# 237061
Tampa, Florida, 33606, United States
Children's Healthcare of Atlanta - Ferry Rd /ID# 237003
Atlanta, Georgia, 30342-1605, United States
University of Maryland Medical Center /ID# 234353
Baltimore, Maryland, 21201-1544, United States
Duplicate_Children's Mercy Hospital and Clinics /ID# 237800
Kansas City, Missouri, 64108, United States
Robert Wood Johnson Univ Hosp /ID# 237862
New Brunswick, New Jersey, 08901, United States
NYU School of Medicine /ID# 236783
New York, New York, 10016, United States
SUNY Upstate Medical University /ID# 236831
Syracuse, New York, 13210, United States
Duke University Medical Center /ID# 234315
Durham, North Carolina, 27705-4410, United States
Cleveland Clinic Main Campus /ID# 237564
Cleveland, Ohio, 44195, United States
Hospital de Ninos Dr. Orlando Alassia /ID# 235562
Santa Fe, 3000, Argentina
Grodno Regional Infectious Disease Hospital /ID# 235661
Grodno, 230030, Belarus
Mogilev Regional Children's Hospital /ID# 235657
Mogilev, 212026, Belarus
Vitebsk Regional Clinical Center for Children /ID# 235659
Vitebsk, 210015, Belarus
Duplicate_Hospital Pequeno Princípe /ID# 235629
Curitiba, Paraná, 80250-060, Brazil
Duplicate_Irmandade Santa Casa de Misericórdia de Porto Alegre /ID# 235627
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965
Bulgas, 8000, Bulgaria
MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539
Kozloduy, 3320, Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 237829
Pleven, 5800, Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 237830
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487
Plovdiv, 4000, Bulgaria
UMHAT Sveti Georgi /ID# 237026
Plovdiv, 4002, Bulgaria
UMHAT Kanev /ID# 237809
Rousse, 7002, Bulgaria
Medical center 1 Sevlievo /ID# 237470
Sevlievo, 5400, Bulgaria
MHATEM N.I.Pirogov Septic Surgery Clinic /ID# 235541
Sofia, 1606, Bulgaria
SHAT Hematologic Diseases /ID# 237915
Sofia, 1756, Bulgaria
University Multiprofile Hospital for Active Treatment Prof. Dr. Stoyan Kirkovich /ID# 235543
Stara Zagora, 6000, Bulgaria
Hospital de Ninos Dr. Roberto del Rio /ID# 235568
Independencia, 8380418, Chile
Hospital El Carmen de Maipú /ID# 235570
Santiago, 8320000, Chile
Fundacion Cardioinfantil /Id# 238041
Bogota, Cundinamarca, 111156, Colombia
Unidad De Investigacion Clinica Universidad De La Sabana /ID# 235566
Chía, Cundinamarca, 25175, Colombia
Hospital Universitario San Vic /ID# 238117
Medellín, 50010, Colombia
LTD Unimedi Kakheti Batumi Maternal and Child Healthcare Center /ID# 235643
Batumi, 6010, Georgia
LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry /ID# 235645
Tbilisi, 159, Georgia
LTD M. Iashvili Children's Central Hospital /ID# 235639
Tbilisi, 159, Georgia
LTD Unimedi Kakheti Children New Hospital /ID# 235634
Tbilisi, 159, Georgia
University General Hospital Attikon /ID# 237398
Athens, Attica, 12462, Greece
Papageorgiou General Hospital Thessaloniki /ID# 237505
Stavroupoli (Thessalonikis), Thessaloniki, 55536, Greece
Childrens Hospital of Penteli /ID# 235667
Athens, 15236, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 237186
Thessaloniki, 54642, Greece
Hospital Valle del Sol /ID# 235569
Guatemala City, 1004, Guatemala
Hospital Roosevelt /ID# 235520
Guatemala City, 1011, Guatemala
Hospital del Centro Medico Infectology Department /ID# 235522
Guatemala City, 1016, Guatemala
Daugavpils Regional Hospital /ID# 237022
Daugavpils, LV-5401, Latvia
Liepaja Regional Hospital /ID# 235650
Liepāja, LV-3414, Latvia
University Childrens Hospital /ID# 235648
Riga, LV-1004, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 236947
Kaunas, 50161, Lithuania
Klaipeda Children's Hospital /ID# 235652
Klaipėda, LT- 92144, Lithuania
Duplicate_Children's Hospital Affiliate - Vilnius University Hospital Santariski /ID# 235654
Vilnius, LT-08661, Lithuania
Instituto Nacional de Pediatria /ID# 235506
Coyoacán, Mexico City, 04530, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 237597
Monterrey, Nuevo León, 64460, Mexico
Hospital General Dr. Agustin O'Horan /ID# 235510
Mérida, Yucatán, 97000, Mexico
Hospital Infantil de Mexico Federico Gomez /ID# 235508
Mexico City, 06720, Mexico
Hospital Materno Infantil José Domingo de Obaldía /ID# 235625
Chiriquí, Chiriquí Province, Panama
Hospital Del Niño Dr. José Renán Esquivel /ID# 235572
Panama City, 0816-00383, Panama
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 236920
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 237112
Warsaw, Masovian Voivodeship, 02-507, Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno /ID# 235518
Poznan, 60-734, Poland
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 235606
Sector 2, București, 021105, Romania
Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 235608
Timișoara, Timiș County, 500063, Romania
Spitalul Clinic de Boli infectioase si Tropicale Dr. Victor Babes /ID# 235610
Bucharest, 030303, Romania
Spitalul Clinic Judeatean Mures /ID# 234728
Târgu Mureş, 540142, Romania
Smolensk State Medical University /ID# 236996
Smolensk, 214019, Russia
Stavropol State Medical University /ID# 236239
Stavropol, 355017, Russia
Regional Childrens Hospital /ID# 235560
Vologda, 160022, Russia
Peermed Clinical Trial Centre /ID# 235514
Kempton Park, Gauteng, 1619, South Africa
Mzansi Ethical Research Center /ID# 236480
Middelburg, Mpumalanga, 1055, South Africa
Complejo Hospitalario Universitario de Santiago /ID# 235512
Santiago de Compostela, A Coruna, 15076, Spain
Hospital Sant Joan de Deu /ID# 236797
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Donostia /ID# 237773
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital General Universitario Gregorio Maranon /ID# 236955
Madrid, 28007, Spain
Hospital Universitario La Paz /ID# 237775
Madrid, 28046, Spain
Hospital Universitario y Politecnico La Fe /ID# 237086
Valencia, 46026, Spain
Ivano-Frankivsk Pediatric Regional Clinical Hospital /ID# 235556
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76006, Ukraine
Dnipropetrovsk Regional children's Clinical Hospital /ID# 235558
Dnipro, 49100, Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 237514
Kropyvnytskyi, 25006, Ukraine
Lviv Regional Clinical Hospital /ID# 236921
Lviv, 79010, Ukraine
Ukrainian Medical Stomatological Academy - Children's City Clinical Hospital /ID# 234886
Poltava, 36004, Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 238058
Uzhhorod, 88000, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 28, 2016
Study Start
March 30, 2017
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.