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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study will evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

Official Title

A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

Keywords

Respiratory Syncytial Virus (RSV) Antiviral Lung Transplant

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • Received a LT (single or double) or heart/lung transplant> 90 days prior to screening
  • Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing(starting from when the upper or lower respiratory tract sample is obtained) ≤ 7 days prior to study drug administration on Day 1/baseline
  • New onset or acute worsening of at least 1 of the following respiratory symptoms ≤ 7 days prior to study drug administration: nasal congestion, earache, runny nose,cough, sore throat, shortness of breath, or wheezing
  • An informed consent document signed and dated by the individual
  • A negative urine or serum pregnancy test for females of childbearing potential
  • Agreement from males and females of childbearing potential to use contraception
  • Ability and willingness to complete necessary study procedures

Key Exclusion Criteria:

Related to concomitant or previous medication use:

  • Use of the following lympholytic treatment: anti-thymocyte globulin (ATG), < 3 months; anti-lymphoblast globulin (ALG), < 3 months; muromonab-CD3 (OKT3), < 3 months; rituximab < 6 months; alemtuzumab < 9 months

Related to transplant history:

  • Recipient of any other organ transplant prior to screening, with the exception of a LT (single or double) or heart/lung transplant
  • Recipient of a hematopoietic cell transplant at any time
  • Presence of BOS Stage 3 at screening defined as a FEV1 of 50% or less of baseline

Related to medical condition at screening:

  • Respiratory failure requiring invasive mechanical ventilation
  • Evidence of shock requiring vasopressors
  • Known viral coinfection (including but not limited to influenza, metapneumovirus,human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or lower respiratory tract ≤ 14 days prior to screening unless discussed with the medical monitor and deemed acceptable
  • Active systemic infection or infectious pneumonia of any etiology (ie, bacterial,viral [other than RSV] or fungal), including aspiration pneumonia, that is considered clinically significant by the investigator unless discussed with the medical monitor and deemed acceptable
  • Pregnant or lactating females
  • Evidence of recent and rapidly deteriorating lung function, occurring before the onset of the current viral respiratory infection

Related to allergies:

  • Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc)
  • History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic epidermal necrolysis response to sulfa drugs

Related to laboratory values:

  • Clinically significant kidney dysfunction
  • Clinically significant liver function test abnormalities
  • Clinically significant elevations in total bilirubin (TB), as determined by the investigator

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

Locations

  • San Francisco, California, United States
  • Stanford, California, United States
  • Los Angeles, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02534350
Phase
Phase 2
Lead Scientist
Steven Hays
Study Type
Interventional
Last Updated
April 1, 2017