- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534350
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
November 1, 2018 updated by: Gilead Sciences
A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia
-
-
Queensland
-
Brisbane, Queensland, Australia
-
-
Western Australia
-
Murdoch, Western Australia, Australia
-
-
-
-
-
Brussels, Belgium
-
Yvoir, Belgium
-
-
-
-
Ontario
-
Toronto, Ontario, Canada
-
-
-
-
-
Strasbourg, France
-
-
-
-
-
Hannover, Germany
-
Munich, Germany
-
-
-
-
-
Rotterdam, Netherlands
-
-
-
-
-
Cambridge, United Kingdom
-
-
-
-
Arizona
-
Phoenix, Arizona, United States
-
-
California
-
Los Angeles, California, United States
-
San Francisco, California, United States
-
Stanford, California, United States
-
-
Florida
-
Tampa, Florida, United States
-
-
Georgia
-
Atlanta, Georgia, United States
-
-
Illinois
-
Chicago, Illinois, United States
-
Maywood, Illinois, United States
-
-
Louisiana
-
New Orleans, Louisiana, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Michigan
-
Ann Arbor, Michigan, United States
-
-
Ohio
-
Cleveland, Ohio, United States
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
-
Pittsburgh, Pennsylvania, United States
-
-
Texas
-
Dallas, Texas, United States
-
San Antonio, Texas, United States
-
-
Washington
-
Seattle, Washington, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Tablets administered orally or via nasogastric (NG) tube once daily
Other Names:
|
Placebo Comparator: Placebo
Placebo tablets for a total of 14 days
|
Tablets administered orally or via NG tube once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 7 days
|
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
|
Up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7
Time Frame: Up to 7 days
|
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.
|
Up to 7 days
|
Percent Change From Study Baseline in FEV1% Predicted Value
Time Frame: Baseline; Day 28
|
FEV1 is defined as forced expiratory volume in the first second.
|
Baseline; Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2015
Primary Completion (Actual)
February 20, 2017
Study Completion (Actual)
September 27, 2017
Study Registration Dates
First Submitted
August 25, 2015
First Submitted That Met QC Criteria
August 25, 2015
First Posted (Estimate)
August 27, 2015
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-218-1797
- 2015-002287-16 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Syncytial Virus (RSV)
-
University of RochesterActive, not recruitingRespiratory Syncytial Virus (RSV)United States
-
University of OxfordInnovative Medicines Initiative; Respiratory syncytial virus consortium in...Active, not recruitingRespiratory Syncytial Virus (RSV)United Kingdom
-
Enanta Pharmaceuticals, IncCompletedRespiratory Syncytial Virus (RSV)United States
-
GlaxoSmithKlineCompletedRespiratory Syncytial Virus (RSV)Belgium
-
NovavaxPATHCompleted
-
Enanta Pharmaceuticals, IncRecruitingRespiratory Syncytial Virus (RSV)United States, Spain, Israel, Australia, Germany, Korea, Republic of, Taiwan, United Kingdom, Argentina, Brazil, New Zealand, Poland, Romania, South Africa, Mexico
-
NovavaxCompletedRespiratory Syncytial Virus (RSV)United States
-
NovavaxCompletedRespiratory Syncytial Virus (RSV)United States
-
VaxartCompletedRespiratory Syncytial Virus (RSV)United States
-
PfizerCompletedRESPIRATORY SYNCYTIAL VIRUS (RSV)United States
Clinical Trials on Presatovir
-
Gilead SciencesCompletedRespiratory Syncytial Virus InfectionKorea, Republic of, Australia, Israel, New Zealand, Netherlands, United States, France, United Kingdom, Italy, Belgium, Poland
-
Gilead SciencesCompletedRespiratory Syncytial Virus InfectionUnited States, France, Sweden, Korea, Republic of, Switzerland
-
Gilead SciencesCompletedRespiratory Syncytial VirusKorea, Republic of, Taiwan, Israel, United States, France, Singapore, Sweden, Australia, Canada, United Kingdom, Brazil, Germany, Netherlands, Spain, Switzerland