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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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 - 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
Timepoint [1] 0 0
Baseline; Day 9
Primary outcome [2] 0 0
Percentage of Participants Who Developed a Lower Respiratory Tract Complication
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
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
Sex
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
23/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2017
Sample size
Target
Accrual to date
Final
189
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
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
Georgia
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United States of America
State/province [4] 0 0
Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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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
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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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
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France
State/province [26] 0 0
Suresnes
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France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Germany
State/province [28] 0 0
Wurzburg
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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
Country [33] 0 0
Israel
State/province [33] 0 0
Ramat Gan
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Aviv
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Korea, Republic of
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Seoul
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Netherlands
State/province [36] 0 0
Amsterdam
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Netherlands
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Rotterdam
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Singapore
State/province [38] 0 0
Singapore
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Spain
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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
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Taipei
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Taiwan
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol: Original https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_000.pdf
Study protocol Study Protocol: Amendment 1 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_001.pdf
Study protocol Study Protocol: Amendment 2 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_002.pdf
Study protocol Study Protocol: Amendment 3 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_003.pdf
Study protocol Study Protocol: Amendment 5 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_004.pdf
Study protocol Study Protocol: Amendment 6 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_005.pdf
Study protocol Study Protocol: Amendment 7 https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/Prot_006.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/08/NCT02254408/SAP_007.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02254408