Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

July 10, 2018 updated by: Gilead Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Presatovir
Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
Other Names:
  • GS-5806
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.
Drug: Placebo
Tablets administered orally or via nasogastric tube

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9
Time Frame: Baseline; 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
Percentage of Participants Who Developed a Lower Respiratory Tract Complication
Time Frame: Up to Day 28

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
Time Frame: Up to Day 28

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-218-0108
  • 2014-002474-36 (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.

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