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

NCT ID: NCT02534350

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-09-27

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Presatovir

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

Group Type: EXPERIMENTAL

Presatovir

Intervention Type: DRUG

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

Placebo

Placebo tablets for a total of 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets administered orally or via NG tube once daily

Interventions

Presatovir

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

Intervention Type: DRUG

Placebo

Tablets administered orally or via NG tube once daily

Intervention Type: DRUG

Other Intervention Names

GS-5806

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Phoenix, Arizona, United States

Los Angeles, California, United States

San Francisco, California, United States

Stanford, California, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Seattle, Washington, United States

Sydney, New South Wales, Australia

Brisbane, Queensland, Australia

Murdoch, Western Australia, Australia

Brussels, , Belgium

Yvoir, , Belgium

Toronto, Ontario, Canada

Strasbourg, , France

Hanover, , Germany

Munich, , Germany

Rotterdam, , Netherlands

Cambridge, , United Kingdom

Countries

United States; Australia; Belgium; Canada; France; Germany; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36964084 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Original

View Document

Document Type: Study Protocol: Amendment 1

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol: Amendment 2

View Document

Other Identifiers

2015-002287-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-218-1797

Identifier Type: -

Identifier Source: org_study_id