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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02254408




Registration number
NCT02254408
Ethics application status
Date submitted
29/09/2014
Date registered
1/10/2014
Date last updated
6/08/2018

Titles & IDs
Public title
Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
Secondary ID [1] 0 0
2014-002474-36
Secondary ID [2] 0 0
GS-US-218-0108
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Presatovir - Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.

Placebo Comparator: Placebo - Participants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.


Treatment: Drugs: Presatovir
Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube

Treatment: Drugs: Placebo
Tablets administered orally or via nasogastric tube

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

Outcomes
Primary outcome [1] 0 0
Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9 - The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Timepoint [1] 0 0
Baseline; Day 9
Primary outcome [2] 0 0
Percentage of Participants Who Developed a Lower Respiratory Tract Complication - A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee:
Primary RSV lower respiratory tract infection (LRTI)
Secondary bacterial LRTI
LRTI due to unusual pathogens
Lower respiratory tract complication of unknown etiology
Timepoint [2] 0 0
Up to Day 28
Secondary outcome [1] 0 0
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality - Participants were considered to have an event if either condition is met:
Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or;
Participant dies prior to or on Day 28
Timepoint [1] 0 0
Up to Day 28

Eligibility
Key inclusion criteria
- Received an autologous or allogeneic HCT using any conditioning regimen

- Documented to be RSV-positive as determined by local testing (eg, polymerase chain
reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)
using an upper respiratory tract sample collected = 6 days prior to Day 1

- New onset of at least 1 of the following respiratory symptoms for = 7 days prior to
Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of
these chronic (associated with a previously existing diagnosis, eg, chronic
rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms = 7 days
prior to Day 1

- No evidence of new abnormalities consistent with lower respiratory tract infection
(LRTI) on a chest X-ray relative to the most recent chest X-ray, as determined by the
local radiologist. If a chest X-ray is not available or was not obtained during
standard care < 48 hours prior to screening, a chest X-ray must be obtained for
screening

- O2 saturation = 92% on room air

- An informed consent document signed and dated by the participant or a legal guardian
of the participant and the investigator or his/her designee

- A negative urine or serum pregnancy test is required for female participants (unless
surgically sterile or greater than two years post-menopausal)

- Male and female participants of childbearing potential must agree to contraceptive
requirements as described in the study protocol

- Willingness to complete necessary study procedures and have available a working
telephone or email
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Related to concomitant or previous medication use:

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

Related to medical history:

- Pregnant, breastfeeding, or lactating females

- Unable to tolerate nasal sampling required for this study, as determined by the
investigator

- Known history of HIV/AIDS with a CD4 count <200 cells/µL within the last month

- History of drug and/or alcohol abuse that, in the opinion of the investigator, may
prevent adherence to study activities

Related to medical condition at screening:

- Documented to be positive for other respiratory viruses (limited to influenza,
parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus)
within 7 days prior to the screening visit, as determined by local testing (additional
testing is not required)

- Clinically significant bacteremia or fungemia within 7 days prior to screening that
has not been adequately treated, as determined by the investigator

- Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to
screening that has not been adequately treated, as determined by the investigator

- Excessive nausea/vomiting at screening, as determined by the investigator, or an
inability to swallow pills that precludes oral administration of the investigational
medical product (for participants without an nasogastric tube in place)

- Any condition which, in the opinion of the investigator, would prevent full
participation in this trial or would interfere with the evaluation of the trial
endpoints

Related to laboratory results:

- Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)

- Clinically significant aspartate aminotransferase/alanine aminotransferase, as
determined by the investigator

- Clinically significant total bilirubin, as determined by the investigator

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 administering the treatment/s
The people assessing the outcomes
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
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
Country [6] 0 0
United States of America
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Massachusetts
Country [7] 0 0
United States of America
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Michigan
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United States of America
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Minnesota
Country [9] 0 0
United States of America
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Missouri
Country [10] 0 0
United States of America
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New York
Country [11] 0 0
United States of America
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North Carolina
Country [12] 0 0
United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
Country [15] 0 0
United States of America
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Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Brazil
State/province [19] 0 0
Porto Alegre
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Brazil
State/province [21] 0 0
São Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Calgary
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Suresnes
Country [27] 0 0
France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Germany
State/province [28] 0 0
Wurzburg
Country [29] 0 0
Israel
State/province [29] 0 0
Beer Sheva
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
State/province [37] 0 0
Rotterdam
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Singapore
State/province [38] 0 0
Singapore
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Spain
State/province [39] 0 0
Seville
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Sweden
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Stockholm
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Switzerland
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Basel
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
State/province [44] 0 0
Taipei
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Taiwan
State/province [45] 0 0
Taoyuan
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Leeds
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

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 respiratory
syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant
(HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of
presatovir on development of lower respiratory tract complication, being free of any
supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety,
and tolerability of presatovir.
Trial website
https://clinicaltrials.gov/show/NCT02254408
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