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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02254408
Other study ID # GS-US-218-0108
Secondary ID 2014-002474-36
Status Completed
Phase Phase 2
First received
Last updated
Start date January 23, 2015
Est. completion date July 14, 2017

Study information

Verified date July 2018
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date July 14, 2017
Est. primary completion date July 14, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Drug:
Presatovir
Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
Placebo
Tablets administered orally or via nasogastric tube

Locations

Country Name City State
Australia Royal Brisbane & Women's Hospital Herston
Australia Royal Melbourne Hospital Melbourne
Australia Westmead Hospital Westmead New South Wales
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre
Brazil Hospital Israelita Albert Einstein Sao Paulo
Brazil Hospital Universitario USP Sao Paulo
Brazil Fundação Antonio Prudente - Hospital do Câncer AC Camargo São Paulo
Brazil Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto São Paulo
Brazil Hospital Santa Marcelina São Paulo
Brazil Instituto Brasileiro de Controle do Câncer-IBCC São Paulo
Canada Tom Baker Cancer Centre Calgary
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
France CHU de Bordeaux Bordeaux
France Hopital Saint-Louis, APHP Paris
France Hopital Foch Suresnes
France Institut Universitaire du Cancer Oncopole Toulouse
Germany Universitatsklinikum Wurzburg Wurzburg
Israel Soroka Medical Center Beer Sheva
Israel Rambam Medical Center Haifa
Israel Hadassah Medical Center Jerusalem
Israel Rabin Medical Center Petah Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul Saint Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Netherlands VUmc cancer center Amsterdam
Netherlands Erasmus Medical Center (Rotterdam) Rotterdam
Singapore Singapore General Hospital Singapore
Singapore UMC National University Health System Singapore
Spain Hospital universitario Virgen del Rocio Seville
Sweden Karolinska Institutet Stockholm
Switzerland University Clinic Basel Basel
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation-LinKou Branch Taoyuan
United Kingdom Leeds Teaching Hospitals Trust Leeds
United Kingdom King's College Hospital London
United States University of Michigan Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States NorthSide Medical Center Atlanta Georgia
United States John Hopkins Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States University of Massachusetts Memorial Cancer Center Boston Massachusetts
United States Northwestern University Chicago Illinois
United States University of Chicago Chicago Illinois
United States University Hospital Case Medical Cleveland Ohio
United States Wayne State University Detroit Michigan
United States City of Hope Duarte California
United States Duke University Durham North Carolina
United States MD Anderson Cancer Center Houston Texas
United States UCLA David Geffen School of Medicine Los Angeles California
United States Loyola University Maywood Illinois
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Memorial Sloan Kettering New York New York
United States New York Presbyterian Hospital Cornell Medical Center New York New York
United States Mayo Clinic Arizona Phoenix Arizona
United States Oregon Health Sciences University Portland Oregon
United States Washington University Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States Texas Transplant Institute (SCRI) San Antonio Texas
United States Fred Hutchison Cancer Research Center Seattle Washington
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Israel,  Korea, Republic of,  Netherlands,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline; Day 9
Primary 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
Up to Day 28
Secondary 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
Up to Day 28
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