Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

NCT02534350 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-218-17972015-002287-16
• Study Type: interventional
• Target: 61
• Locations: 8 countries
• Sites: 28

Brief Summary

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Respiratory Syncytial Virus (RSV); Antiviral; Lung Transplant

Outcome Measures

Primary Outcomes (2)

• Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

  Up to 7 days

• Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

  Up to 7 days

Secondary Outcomes (2)

• Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7

  Up to 7 days

• Percent Change From Study Baseline in FEV1% Predicted Value

  Baseline; Day 28

Study Arms (2)

Presatovir

EXPERIMENTAL

Presatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14

Drug: Presatovir

Placebo

PLACEBO COMPARATOR

Placebo tablets for a total of 14 days

Drug: Placebo

Interventions

Presatovir DRUG

Tablets administered orally or via nasogastric (NG) tube once daily

Also known as: GS-5806

Presatovir

Placebo DRUG

Tablets administered orally or via NG tube once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years of age who have 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 investigational medicinal product (IMP) administration on Day 1/Baseline
• New onset or acute worsening, if the symptom is chronic, of at least 1 of the following respiratory symptoms ≤ 7 days prior to IMP administration on Day 1/Baseline: nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing
• A negative local urine or serum pregnancy test for female subjects of childbearing potential at Screening, within 1 day prior to IMP administration. When available, existing local pregnancy test results obtained prior to Screening may be used, provided the testing was completed within 1 day prior to IMP administration
• Agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception

You may not qualify if:

• Related to concomitant or previous medication use:
• Use of any non-marketed (according to region) investigational agents within 30 days, OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whichever is longer, OR use of any prior investigational RSV vaccines
• Use of a strong or moderate cytochrome P450 enzyme (CYP) 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 IMP
• 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
• Related to medical condition at Screening:
• 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
• Related to laboratory values:
• Clinically significant kidney dysfunction as defined by: An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) study 4 parameter equation obtained from screening laboratory measurements or via local laboratory measurements obtained ≤ 7 days prior to Screening. The eGFR may be manually calculated or the reported eGFR value may be used, but any automatically calculated eGFR must be calculated using the MDRD equation.
• Clinically significant liver function test abnormalities as defined by an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN) obtained in screening laboratory measurements or via local laboratory measurements obtained ≤ 7 days prior to Screening
• Clinically significant elevations in total bilirubin (TB), as determined by the investigator

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (28)

Unknown Facility

Phoenix, Arizona, United States

Location

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Los Angeles, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Sydney, New South Wales, Australia

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Brisbane, Queensland, Australia

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Murdoch, Western Australia, Australia

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Brussels, Belgium

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Yvoir, Belgium

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Toronto, Ontario, Canada

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Strasbourg, France

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Hanover, Germany

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Munich, Germany

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Rotterdam, Netherlands

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Cambridge, United Kingdom

Location

Related Publications (1)

• Gottlieb J, Torres F, Haddad T, Dhillon G, Dilling DF, Knoop C, Rampolla R, Walia R, Ahya V, Kessler R, Budev M, Neurohr C, Glanville AR, Jordan R, Porter D, McKevitt M, German P, Guo Y, Chien JW, Watkins TR, Zamora MR. A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant. J Heart Lung Transplant. 2023 Jul;42(7):908-916. doi: 10.1016/j.healun.2023.01.013. Epub 2023 Feb 7.

  PMID: 36964084 DERIVED

MeSH Terms

Interventions

presatovir

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 27, 2015
• Study Start: December 31, 2015
• Primary Completion: February 20, 2017
• Study Completion: September 27, 2017
• Last Updated: November 28, 2018
• Results First Posted: November 28, 2018

Record last verified: 2018-11

Locations

FR (1); BE (2); DE (2); AU (3); CA (1); NL (1); US (17); GB (1)