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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02534350




Registration number
NCT02534350
Ethics application status
Date submitted
25/08/2015
Date registered
27/08/2015
Date last updated
28/11/2018

Titles & IDs
Public title
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
Scientific title
A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
Secondary ID [1] 0 0
2015-002287-16
Secondary ID [2] 0 0
GS-US-218-1797
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV) 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

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

Experimental: Presatovir - Presatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14

Placebo Comparator: Placebo - Placebo tablets for a total of 14 days


Treatment: Drugs: Presatovir
Tablets administered orally or via nasogastric (NG) tube once daily

Treatment: Drugs: Placebo
Tablets administered orally or via NG tube once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set
Timepoint [1] 0 0
Up to 7 days
Primary outcome [2] 0 0
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is = Median
Timepoint [2] 0 0
Up to 7 days
Secondary outcome [1] 0 0
Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 - The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Timepoint [1] 0 0
Up to 7 days
Secondary outcome [2] 0 0
Percent Change From Study Baseline in FEV1% Predicted Value - FEV1 is defined as forced expiratory volume in the first second.
Timepoint [2] 0 0
Baseline; Day 28

Eligibility
Key inclusion criteria
Key

- Males and females =18 years of age who have received a LT (single or double) or
heart/lung transplant > 90 days prior to Screening

- Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing
(starting from when the upper or lower respiratory tract sample is obtained) = 7 days
prior to investigational medicinal product (IMP) administration on Day 1/Baseline

- New onset or acute worsening, if the symptom is chronic, of at least 1 of the
following respiratory symptoms = 7 days prior to IMP administration on Day 1/Baseline:
nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or
wheezing

- A negative local urine or serum pregnancy test for female subjects of childbearing
potential at Screening, within 1 day prior to IMP administration. When available,
existing local pregnancy test results obtained prior to Screening may be used,
provided the testing was completed within 1 day prior to IMP administration

- Agreement from male and female subjects of childbearing potential who engage in
heterosexual intercourse to use protocol specified method(s) of contraception

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Related to concomitant or previous medication use:

- Use of any non-marketed (according to region) investigational agents within 30 days,
OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5
half-lives of Screening, whichever is longer, OR use of any prior investigational RSV
vaccines

- Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not
limited to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan,
etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP

Related to transplant history:

• Recipient of any other organ transplant prior to Screening, with the exception of a LT
(single or double) or heart/lung transplant

Related to medical condition at Screening:

- Known viral coinfection (including but not limited to influenza, metapneumovirus,
human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or
lower respiratory tract = 14 days prior to Screening unless discussed with the medical
monitor and deemed acceptable

- Active systemic infection or infectious pneumonia of any etiology (ie, bacterial,
viral [other than RSV] or fungal), including aspiration pneumonia, that is considered
clinically significant by the investigator unless discussed with the medical monitor
and deemed acceptable

Related to laboratory values:

- Clinically significant kidney dysfunction as defined by: An estimated glomerular
filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated by the Modification of Diet
in Renal Disease (MDRD) study 4 parameter equation obtained from screening laboratory
measurements or via local laboratory measurements obtained = 7 days prior to
Screening. The eGFR may be manually calculated or the reported eGFR value may be used,
but any automatically calculated eGFR must be calculated using the MDRD equation.

- Clinically significant liver function test abnormalities as defined by an alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit
of normal (ULN) obtained in screening laboratory measurements or via local laboratory
measurements obtained = 7 days prior to Screening

- Clinically significant elevations in total bilirubin (TB), as determined by the
investigator

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Murdoch
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Yvoir
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
France
State/province [16] 0 0
Strasbourg
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Munich
Country [19] 0 0
Netherlands
State/province [19] 0 0
Rotterdam
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the effect of presatovir on nasal
respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients
with acute respiratory symptoms.
Trial website
https://clinicaltrials.gov/show/NCT02534350
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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
Other publications