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Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254421
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : May 11, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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 lower respiratory tract infection (LRTI).

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infection Drug: Presatovir Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 Lower Respiratory Tract
Actual Study Start Date : January 31, 2015
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017
Arms and Interventions
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Arm Intervention/treatment
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 Name: GS-5806
Placebo Comparator: Placebo
Participants will receive placebo to match 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: Placebo
Placebo to match presatovir administered orally or via nasogastric tube


Outcome Measures
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Primary Outcome Measures :
  1. Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9 [ Time Frame: Baseline 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 factors.


Secondary Outcome Measures :
  1. Number of Supplemental O2-Free Days Through Day 28 [ Time Frame: Up to Day 28 ]
  2. Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28 [ Time Frame: Up to Day 28 ]
  3. Percentage of All-Cause Mortality Among Participants Through Day 28 [ Time Frame: Up to Day 28 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Received an autologous or allogeneic HCT using any conditioning regimen
  • Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to screening, determined to be consistent with LRTI by the local radiologist, relative to the most recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be obtained for screening.
  • Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous sputum) respiratory tract as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture). All samples must have been collected ≤ 6 days prior to Day 1, or as determined at screening as per protocol.
  • An informed consent document signed and dated by the participant or a legal guardian of the participant and 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

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
  • Use of a moderate or strong cytochrome P450 enzyme 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 study drug

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 conditions:

  • Requiring invasive mechanical ventilation at the time of randomization
  • Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus), from the lower respiratory tract sample as determined by local testing
  • 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 individuals without an NG 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254421


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] June 9, 2014
Study Protocol: Amendment 1  [PDF] July 31, 2014
Study Protocol: Amendment 2  [PDF] September 22, 2014
Study Protocol: Amendment 3  [PDF] October 21, 2014
Study Protocol: Amendment 5 (Amendment 4 not implemented)  [PDF] June 30, 2015
Study Protocol: Amendment 6  [PDF] November 20, 2015
Study Protocol: Amendment 7  [PDF] March 28, 2016
Statistical Analysis Plan  [PDF] June 27, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02254421    
Other Study ID Numbers: GS-US-218-1502
2014-002475-29 ( EudraCT Number )
First Posted: October 1, 2014    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: September 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Respiratory Syncytial Virus (RSV)
Antiviral
Hematopoietic Cell Transplant (HCT)
Lower respiratory tract infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Syncytial Virus Infections
Virus Diseases
 Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections