Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02534350 |
Date of registration:
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25/08/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
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Scientific title:
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A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection |
Date of first enrolment:
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December 31, 2015 |
Target sample size:
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61 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02534350 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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France
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Germany
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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Gilead Study Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- 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 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Syncytial Virus (RSV)
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Intervention(s)
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Drug: Placebo
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Drug: Presatovir
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Primary Outcome(s)
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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
[Time Frame: Up to 7 days]
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Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set
[Time Frame: Up to 7 days]
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Secondary Outcome(s)
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Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7
[Time Frame: Up to 7 days]
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Percent Change From Study Baseline in FEV1% Predicted Value
[Time Frame: Baseline; Day 28]
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Secondary ID(s)
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2015-002287-16
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GS-US-218-1797
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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