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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03502694




Registration number
NCT03502694
Ethics application status
Date submitted
11/04/2018
Date registered
19/04/2018
Date last updated
15/11/2018

Titles & IDs
Public title
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus
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 (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus
Secondary ID [1] 0 0
2017-001696-22
Secondary ID [2] 0 0
CR108378
Universal Trial Number (UTN)
Trial acronym
STEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metapneumovirus 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 (Low-Dose Lumicitabine) - Participants will receive a single 750 milligram (mg) loading dose (LD) (Dose 1) of lumicitabine and matching placebo followed by nine 250 mg tablets as maintenance doses (MDs) (Doses 2 to 10) of lumicitabine and matching placebo administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).

Experimental: Regimen B (High-Dose Lumicitabine) - Participants will receive a single 1000 mg LD (Dose 1) of lumicitabine followed by nine 500 mg tablets as MDs (Doses 2 to 10) of lumicitabine and matching placebo tablet, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).

Placebo comparator: Regimen C (Placebo) - Participants will receive a placebo LD (Dose 1) followed by nine MDs (Doses 2 to 10) of matching placebo, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).


Treatment: Drugs: Lumicitabine
Participants will receive loading dose and maintenance dose of lumicitabine tablets orally.

Treatment: Drugs: Placebo
Participants will receive matching placebo tablets orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration-Time Curve (AUC) of Human Metapneumovirus (hMPV) Viral Load
Timepoint [1] 0 0
Baseline up to Day 7
Secondary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
Up to 28 days
Secondary outcome [2] 0 0
Number of Participants with an Abnormal Physical Examination Findings (Height, Body Weight, Respiratory System, Nose, Ear, Throat, Facial and Neck Lymph Nodes, and Skin Examination) as a Measure of Safety and Tolerability
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [3] 0 0
Number of Participants with an Abnormal Vital Signs/Peripheral Capillary Oxygen Saturation (SpO2) Reading as a Measure of Safety and Tolerability
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [4] 0 0
Number of Participants with an Abnormal Electrocardiogram (ECG) Reading as a Measure of Safety and Tolerability
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
Timepoint [5] 0 0
Up to 28 days
Secondary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109
Timepoint [6] 0 0
Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose
Secondary outcome [7] 0 0
Concentration at 12 Hours Postdose (C12h) of JNJ-63549109
Timepoint [7] 0 0
Days 1, 2, and 5/6: 12 hours postdose
Secondary outcome [8] 0 0
Area Under the Plasma Concentration-Time Curve (AUC) of JNJ-63549109
Timepoint [8] 0 0
Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose
Secondary outcome [9] 0 0
Ordinal Scale
Timepoint [9] 0 0
Day of last dose (Day 5 or Day 6)
Secondary outcome [10] 0 0
Length of Hospital Stay from Admission to Discharge
Timepoint [10] 0 0
From admission to discharge (Up to 28 days)
Secondary outcome [11] 0 0
Length of Hospital Stay from Admission to Readiness for Discharge
Timepoint [11] 0 0
From admission to readiness for discharge discharge (Up to 28 days)
Secondary outcome [12] 0 0
Length of Hospital Stay from Study Treatment Initiation to Discharge
Timepoint [12] 0 0
From study treatment initiation to discharge (Up to 28 days)
Secondary outcome [13] 0 0
Length of Hospital Stay from Study Treatment Initiation to Readiness for Discharge
Timepoint [13] 0 0
From study treatment initiation to readiness for discharge (Up to 28 days)
Secondary outcome [14] 0 0
Percentage of Participants Requiring Admission to the Intensive Care Unit (ICU)
Timepoint [14] 0 0
Up to 28 days
Secondary outcome [15] 0 0
Duration of ICU Stay
Timepoint [15] 0 0
Up to 28 days
Secondary outcome [16] 0 0
Percentage of Participants Requiring Oxygen Supplementation/Noninvasive Mechanical Ventilation Support
Timepoint [16] 0 0
Up to 28 days
Secondary outcome [17] 0 0
Duration of Oxygen Supplementation/Noninvasive Mechanical Ventilation Support
Timepoint [17] 0 0
Up to 28 days
Secondary outcome [18] 0 0
Percentage of Participants Requiring Invasive Mechanical Ventilation Support
Timepoint [18] 0 0
Up to 28 days
Secondary outcome [19] 0 0
Duration of Invasive Mechanical Ventilation Support
Timepoint [19] 0 0
Up to 28 days
Secondary outcome [20] 0 0
Time to no Longer Requiring Supplemental Oxygen
Timepoint [20] 0 0
Up to 28 days
Secondary outcome [21] 0 0
Time to Clinical Stability
Timepoint [21] 0 0
Up to 28 days
Secondary outcome [22] 0 0
Number of Hours from Initiation of Study Treatment Until SpO2 is Greater Than or equal to (>=) 93 Percent (%) on Room air
Timepoint [22] 0 0
Up to 28 days
Secondary outcome [23] 0 0
Time for Respiratory Rate to Return to Pre-hMPV Infection Status
Timepoint [23] 0 0
Up to 28 days
Secondary outcome [24] 0 0
Time for Peripheral Capillary Oxygen Saturation (SpO2) Return to Pre-hMPV Infection Status
Timepoint [24] 0 0
Up to 28 days
Secondary outcome [25] 0 0
Time for Body Temperature to Return to Pre-hMPV Infection Status
Timepoint [25] 0 0
Up to 28 days
Secondary outcome [26] 0 0
Percentage of Enrolled Participants Who Require Hydration and/or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
Timepoint [26] 0 0
Up to 28 days
Secondary outcome [27] 0 0
Number of Participants With Bacterial Superinfections Reported as AEs
Timepoint [27] 0 0
Up to 28 days
Secondary outcome [28] 0 0
Number of Participants With Treatment-Emergent Complications
Timepoint [28] 0 0
Up to 28 days
Secondary outcome [29] 0 0
Change From Baseline in the National Early Warning Score (NEWS) Over Time
Timepoint [29] 0 0
Baseline up to 28 days
Secondary outcome [30] 0 0
Number of Participants With All-Cause Mortality
Timepoint [30] 0 0
Up to 28 days
Secondary outcome [31] 0 0
Time to Return to Pre-hMPV Infection Functional Status (Katz Activities of Daily Living [ADL] score)
Timepoint [31] 0 0
Up to 28 Days
Secondary outcome [32] 0 0
hMPV Viral Load Over Time
Timepoint [32] 0 0
Up to 28 days
Secondary outcome [33] 0 0
Peak hMPV Viral Load
Timepoint [33] 0 0
Up to 28 days
Secondary outcome [34] 0 0
Time to Peak hMPV Viral Load
Timepoint [34] 0 0
Up to 28 days
Secondary outcome [35] 0 0
Rate of Decline of hMPV Viral Load
Timepoint [35] 0 0
Up to 28 days
Secondary outcome [36] 0 0
Time to hMPV Ribonucleic Acid (RNA) Being Undetectable
Timepoint [36] 0 0
Up to 28 days
Secondary outcome [37] 0 0
Percentage of Participants With Undetectable hMPV Viral Load at Each Timepoint
Timepoint [37] 0 0
From Day 1 to Day 7 and on Day 10, Day 14, and Day 28
Secondary outcome [38] 0 0
AUC of hMPV Viral Load From Baseline up to Day 10
Timepoint [38] 0 0
Baseline up to Day 10
Secondary outcome [39] 0 0
AUC of hMPV Viral Load from Baseline up to Day 14
Timepoint [39] 0 0
Baseline up to Day 14
Secondary outcome [40] 0 0
AUC of hMPV Viral Load in Participants Assigned to a Longer Dosing Duration From Baseline Until 1 day After the Last Dose of Study Drug
Timepoint [40] 0 0
Baseline Until 1 day After the Last Dose of Study Drug (approximately up to 12 days)
Secondary outcome [41] 0 0
Number of Participants With Postbaseline Changes in the hMPV Polymerase Lgene and Other Regions of the hMPV Genome Compared With Baseline Sequences
Timepoint [41] 0 0
Up to 28 days

Eligibility
Key inclusion criteria
* Participants 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
* Participants diagnosed with human metapneumovirus (hMPV) infection using a rapid polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria)
* Participants with an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to (<=)5 days from the anticipated time of randomization
* With the exception of the symptoms related to hMPV infection, participants must be medically stable on the basis of physical examination, medical history, 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 hMPV infection. This determination must be recorded in the participant's source documents and initialed by the investigator
* A woman must have a negative urine pregnancy test (beta-human chorionic gonadotropin [b-hCG]) 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 immunocompromised within the past 12 months, whether due to underlying medical condition (for example, malignancy or genetic disorder) or medical therapy (for 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 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 a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis

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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
5/11/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2020
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [6] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3050 - Melbourne
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
2145 - 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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Argentina
State/province [7] 0 0
Bahia Blanca
Country [8] 0 0
Argentina
State/province [8] 0 0
Bahía Blanca
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad De Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad De La Plata
Country [12] 0 0
Argentina
State/province [12] 0 0
Cordoba
Country [13] 0 0
Argentina
State/province [13] 0 0
La Plata
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Brazil
State/province [15] 0 0
Ribeirao Preto
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Kozloduy
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Pernik
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Troyan
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Veliko Tarnovo
Country [22] 0 0
France
State/province [22] 0 0
Bois Guillaume
Country [23] 0 0
France
State/province [23] 0 0
Caen
Country [24] 0 0
France
State/province [24] 0 0
Colombes
Country [25] 0 0
France
State/province [25] 0 0
Créteil
Country [26] 0 0
France
State/province [26] 0 0
Dijon
Country [27] 0 0
France
State/province [27] 0 0
La Tronche
Country [28] 0 0
France
State/province [28] 0 0
Nîmes
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Poitiers
Country [31] 0 0
France
State/province [31] 0 0
St Priest En Jarez
Country [32] 0 0
France
State/province [32] 0 0
Suresnes
Country [33] 0 0
France
State/province [33] 0 0
Tours Cedex
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Gifu
Country [36] 0 0
Japan
State/province [36] 0 0
Hamamatue
Country [37] 0 0
Japan
State/province [37] 0 0
Isahaya
Country [38] 0 0
Japan
State/province [38] 0 0
Izumo
Country [39] 0 0
Japan
State/province [39] 0 0
Kitakyusyu
Country [40] 0 0
Japan
State/province [40] 0 0
Kobe-City
Country [41] 0 0
Japan
State/province [41] 0 0
Nagano
Country [42] 0 0
Japan
State/province [42] 0 0
Nagasaki
Country [43] 0 0
Japan
State/province [43] 0 0
Nagoya
Country [44] 0 0
Japan
State/province [44] 0 0
Osaka
Country [45] 0 0
Japan
State/province [45] 0 0
Ota
Country [46] 0 0
Japan
State/province [46] 0 0
Sendai
Country [47] 0 0
Japan
State/province [47] 0 0
Shiogama
Country [48] 0 0
Japan
State/province [48] 0 0
Tokai-Mura
Country [49] 0 0
Japan
State/province [49] 0 0
Tokyo
Country [50] 0 0
Japan
State/province [50] 0 0
Uruma
Country [51] 0 0
Japan
State/province [51] 0 0
Yamagata
Country [52] 0 0
Japan
State/province [52] 0 0
Yamaguchi
Country [53] 0 0
Japan
State/province [53] 0 0
Yukuhashi
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Bucheon
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Daegu
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Incheon
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seongnam
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
Country [59] 0 0
Malaysia
State/province [59] 0 0
Alor Setar
Country [60] 0 0
Malaysia
State/province [60] 0 0
George Town
Country [61] 0 0
Malaysia
State/province [61] 0 0
Kota Bharu
Country [62] 0 0
Malaysia
State/province [62] 0 0
Kuala Lumpur
Country [63] 0 0
Malaysia
State/province [63] 0 0
Kuching
Country [64] 0 0
Malaysia
State/province [64] 0 0
Miri
Country [65] 0 0
Malaysia
State/province [65] 0 0
Taiping
Country [66] 0 0
Netherlands
State/province [66] 0 0
Groningen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Utrecht
Country [68] 0 0
Netherlands
State/province [68] 0 0
Zutphen
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Checiny
Country [71] 0 0
Poland
State/province [71] 0 0
Mrozy
Country [72] 0 0
Poland
State/province [72] 0 0
Olsztyn
Country [73] 0 0
Poland
State/province [73] 0 0
Proszowice
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Engels
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Smolensk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
St. Petersburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Tomsk
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Voronezh
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Yaroslavl
Country [80] 0 0
Spain
State/province [80] 0 0
Elche
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Santiago De Compostela
Country [83] 0 0
Spain
State/province [83] 0 0
Vigo
Country [84] 0 0
Sweden
State/province [84] 0 0
Göteborg
Country [85] 0 0
Sweden
State/province [85] 0 0
Malmö
Country [86] 0 0
Sweden
State/province [86] 0 0
Umeå
Country [87] 0 0
Sweden
State/province [87] 0 0
Uppsala
Country [88] 0 0
Taiwan
State/province [88] 0 0
Kaohsiung
Country [89] 0 0
Taiwan
State/province [89] 0 0
New Taipei
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei
Country [92] 0 0
Ukraine
State/province [92] 0 0
Chernivtsi
Country [93] 0 0
Ukraine
State/province [93] 0 0
Ivano-Frankivsk
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kharkiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03502694