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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02935673




Registration number
NCT02935673
Ethics application status
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
24/12/2019

Titles & IDs
Public title
Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
Scientific title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus
Secondary ID [1] 0 0
2016-001653-40
Secondary ID [2] 0 0
CR108217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lumicitabine
Treatment: Drugs - Placebo

Experimental: Regimen A (Placebo) - Participants of part 1 and part 2 will receive a single loading dose (LD) (Dose 1) followed by 9 maintenance doses (MDs) (Doses 2 to 10) of matching placebo, administered twice daily.

Experimental: Regimen B (low-dose lumicitabine) - Participants of part 1 and part 2 will receive a single 750 mg LD (Dose 1) followed by nine 250 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.

Experimental: Regimen C (High-dose lumicitabine) - Participants of part 2 will receive a single 1000 mg LD (Dose 1) followed by nine 500 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.


Treatment: Drugs: lumicitabine
Oral administration of lumicitabine as tablet.

Treatment: Drugs: Placebo
Oral administration of matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5
Timepoint [2] 0 0
Day 5
Primary outcome [3] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5
Timepoint [4] 0 0
Day 5
Primary outcome [5] 0 0
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1
Timepoint [5] 0 0
Day 1
Primary outcome [6] 0 0
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5
Timepoint [6] 0 0
Day 5
Primary outcome [7] 0 0
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7])
Timepoint [7] 0 0
Day 1 (Baseline) to 7
Secondary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to 28 Days
Secondary outcome [2] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [2] 0 0
Up to 28 Days
Secondary outcome [3] 0 0
Number of Participants With QT Interval Abnormalities
Timepoint [3] 0 0
Up to 28 Days
Secondary outcome [4] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [4] 0 0
Up to 28 Days
Secondary outcome [5] 0 0
Time of Hospital Stay From Study Treatment Initiation to Discharge
Timepoint [5] 0 0
From study treatment initiation to discharge (Up to 28 Days)
Secondary outcome [6] 0 0
Time of Hospital Stay From Admission to Discharge
Timepoint [6] 0 0
From admission to discharge (Up to 28 Days)
Secondary outcome [7] 0 0
Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge
Timepoint [7] 0 0
From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged
Secondary outcome [8] 0 0
Time of Hospital Stay From Admission to Readiness for Discharge
Timepoint [8] 0 0
Up to 28 Days
Secondary outcome [9] 0 0
Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment
Timepoint [9] 0 0
Up to 28 Days
Secondary outcome [10] 0 0
Duration of Intensive Care Unit Stay
Timepoint [10] 0 0
Up to 28 Days
Secondary outcome [11] 0 0
Number of Participants Who Required Supplemental Oxygen
Timepoint [11] 0 0
Up to 28 Days
Secondary outcome [12] 0 0
Time to End of Oxygen Supplementation
Timepoint [12] 0 0
Up to 28 Days
Secondary outcome [13] 0 0
Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms
Timepoint [13] 0 0
Up to 28 Days
Secondary outcome [14] 0 0
Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate
Timepoint [14] 0 0
Up to 28 Days
Secondary outcome [15] 0 0
Time to Return to Pre-RSV Disease Level for Oxygen Saturation
Timepoint [15] 0 0
Up to 28 Days
Secondary outcome [16] 0 0
Time to Return to Pre-RSV Disease Level for Body Temperature
Timepoint [16] 0 0
Up to 28 Days
Secondary outcome [17] 0 0
Number of Participants Who Required Noninvasive Mechanical Ventilation Support
Timepoint [17] 0 0
Up to 28 Days
Secondary outcome [18] 0 0
Time to End of Noninvasive Mechanical Ventilation Support
Timepoint [18] 0 0
Up to 28 Days
Secondary outcome [19] 0 0
Number of Participants Who Required Invasive Mechanical Ventilation Support
Timepoint [19] 0 0
Up to 28 Days
Secondary outcome [20] 0 0
Time to End of Invasive Mechanical Ventilation Support
Timepoint [20] 0 0
Up to 28 Days
Secondary outcome [21] 0 0
Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score
Timepoint [21] 0 0
Up to 28 Days
Secondary outcome [22] 0 0
Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
Timepoint [22] 0 0
Up to 28 Days
Secondary outcome [23] 0 0
Time to Clinical Stability
Timepoint [23] 0 0
Up to 28 Days
Secondary outcome [24] 0 0
Number of Participants in Each Ordinal Scale Category
Timepoint [24] 0 0
Day 5/6 (Day of last study treatment)
Secondary outcome [25] 0 0
Number of Participants With All-Cause Mortality
Timepoint [25] 0 0
Up to 28 Days
Secondary outcome [26] 0 0
RSV RNA Viral Load Over Time
Timepoint [26] 0 0
Days 2, 3, 4, 5, 6, 7, 10, 14, and 28
Secondary outcome [27] 0 0
Peak Viral Load
Timepoint [27] 0 0
Up to 28 Days
Secondary outcome [28] 0 0
Time to Peak Viral Load
Timepoint [28] 0 0
Up to 28 Days
Secondary outcome [29] 0 0
Rate of Decline of Viral Load
Timepoint [29] 0 0
Up to 28 Days
Secondary outcome [30] 0 0
Time to RSV RNA Viral Load Being Undetectable
Timepoint [30] 0 0
Up to 28 Days
Secondary outcome [31] 0 0
Number of Participants With Undetectable Viral Load
Timepoint [31] 0 0
Up to 28 Days
Secondary outcome [32] 0 0
RSV RNA Viral Load AUC up to Day 14
Timepoint [32] 0 0
Up to Day 14
Secondary outcome [33] 0 0
RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration
Timepoint [33] 0 0
Up to 1 Day after the last dose of study drug
Secondary outcome [34] 0 0
Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Timepoint [34] 0 0
Baseline up to 28 Days

Eligibility
Key inclusion criteria
* Hospitalized (or in emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
* Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain reaction (PCR)-based assay with or without co infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria)
* With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator
* A woman must have a negative urine beta human chorionic gonadotropin at screening
* A woman must agree not to donate eggs (ova, oocytes) during the study and for at least 44 days after receiving the last dose of study drug
* Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies A woman must be of non-childbearing potential defined as either: a) Postmenopausal: a postmenopausal state is defined as more than (>) 45 years and no menses for 12 consecutive months without an alternative medical cause, OR Permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active, also included: practicing a highly effective method of contraception (failure rate of less than (<) 1percent (%) per year when used consistently and correctly)
* Participants must have a body weight of at least 50.0 kilogram, at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who are not expected to survive for more than 48 hours
* Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
* Participants who are considered by the investigator to be immuno-compromised within the past 12 months, whether due to underlying medical condition (example, malignancy or genetic disorder) or medical therapy (example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)
* Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis
* Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2)
* Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per millimeter cube (/mm^³), White blood cell count <1,000/mm^³, Absolute neutrophil count <1,000/mm^³

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2018
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Geelong
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- South Brisbane
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Geelong
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
Argentina
State/province [8] 0 0
Bahia Blanca
Country [9] 0 0
Argentina
State/province [9] 0 0
Barrio Parque Velez Sarfield
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad de Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad De La Plata
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
La Plata
Country [16] 0 0
Argentina
State/province [16] 0 0
Rosario
Country [17] 0 0
Belgium
State/province [17] 0 0
Brugge
Country [18] 0 0
Belgium
State/province [18] 0 0
Lier
Country [19] 0 0
Brazil
State/province [19] 0 0
Belo Horizonte
Country [20] 0 0
Brazil
State/province [20] 0 0
Passo Fundo
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Ribeirao Preto
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Kozloduy
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Petrich
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Ruse
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sofia
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Veliko Tarnovo
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
France
State/province [30] 0 0
Colombes
Country [31] 0 0
France
State/province [31] 0 0
Dijon
Country [32] 0 0
France
State/province [32] 0 0
La Tronche
Country [33] 0 0
France
State/province [33] 0 0
Limoges
Country [34] 0 0
France
State/province [34] 0 0
Lyon
Country [35] 0 0
France
State/province [35] 0 0
Morlaix
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Poitiers
Country [39] 0 0
France
State/province [39] 0 0
Suresnes
Country [40] 0 0
France
State/province [40] 0 0
Tours
Country [41] 0 0
Germany
State/province [41] 0 0
Marburg
Country [42] 0 0
Germany
State/province [42] 0 0
Witten
Country [43] 0 0
Japan
State/province [43] 0 0
Fukuoka
Country [44] 0 0
Japan
State/province [44] 0 0
Fukushima
Country [45] 0 0
Japan
State/province [45] 0 0
Gifu
Country [46] 0 0
Japan
State/province [46] 0 0
Gunma
Country [47] 0 0
Japan
State/province [47] 0 0
Hamamatue
Country [48] 0 0
Japan
State/province [48] 0 0
Isahaya
Country [49] 0 0
Japan
State/province [49] 0 0
Izumo
Country [50] 0 0
Japan
State/province [50] 0 0
Kitakyusyu
Country [51] 0 0
Japan
State/province [51] 0 0
Kobe-city,
Country [52] 0 0
Japan
State/province [52] 0 0
Nagasaki
Country [53] 0 0
Japan
State/province [53] 0 0
Nagoya
Country [54] 0 0
Japan
State/province [54] 0 0
Osaka
Country [55] 0 0
Japan
State/province [55] 0 0
Ota
Country [56] 0 0
Japan
State/province [56] 0 0
Sendai
Country [57] 0 0
Japan
State/province [57] 0 0
Seto
Country [58] 0 0
Japan
State/province [58] 0 0
Shiogama
Country [59] 0 0
Japan
State/province [59] 0 0
Tanabe
Country [60] 0 0
Japan
State/province [60] 0 0
Tokai-mura
Country [61] 0 0
Japan
State/province [61] 0 0
Tokyo
Country [62] 0 0
Japan
State/province [62] 0 0
Tsu
Country [63] 0 0
Japan
State/province [63] 0 0
Uruma
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Bucheon
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Daegu
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gwangju
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Incheon
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seongnam
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul
Country [70] 0 0
Malaysia
State/province [70] 0 0
Johor Bharu
Country [71] 0 0
Malaysia
State/province [71] 0 0
Kuala Lumpur
Country [72] 0 0
Malaysia
State/province [72] 0 0
Kuala
Country [73] 0 0
Malaysia
State/province [73] 0 0
Kuching
Country [74] 0 0
Malaysia
State/province [74] 0 0
Melaka
Country [75] 0 0
Malaysia
State/province [75] 0 0
Miri
Country [76] 0 0
Malaysia
State/province [76] 0 0
Taiping
Country [77] 0 0
Mexico
State/province [77] 0 0
Cuernavaca
Country [78] 0 0
Mexico
State/province [78] 0 0
Guadalajara
Country [79] 0 0
Mexico
State/province [79] 0 0
Mexico
Country [80] 0 0
Mexico
State/province [80] 0 0
Monterrey
Country [81] 0 0
Netherlands
State/province [81] 0 0
Leiden
Country [82] 0 0
Netherlands
State/province [82] 0 0
Utrecht
Country [83] 0 0
Poland
State/province [83] 0 0
Bialystok
Country [84] 0 0
Poland
State/province [84] 0 0
Checiny
Country [85] 0 0
Poland
State/province [85] 0 0
Mrozy
Country [86] 0 0
Poland
State/province [86] 0 0
Proszowice
Country [87] 0 0
Spain
State/province [87] 0 0
Elche
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Santiago de Compostela
Country [91] 0 0
Spain
State/province [91] 0 0
Vigo
Country [92] 0 0
Sweden
State/province [92] 0 0
Göteborg
Country [93] 0 0
Sweden
State/province [93] 0 0
Malmö
Country [94] 0 0
Sweden
State/province [94] 0 0
Umeå
Country [95] 0 0
Sweden
State/province [95] 0 0
Uppsala
Country [96] 0 0
Taiwan
State/province [96] 0 0
Kaohsiung
Country [97] 0 0
Taiwan
State/province [97] 0 0
New Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Tainan
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taipei
Country [100] 0 0
United Kingdom
State/province [100] 0 0
London
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.
Trial website
https://clinicaltrials.gov/study/NCT02935673
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02935673