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

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534350
• Other study ID #: GS-US-218-1797
• Secondary ID: 2015-002287-16
• Status: Completed
• Phase: Phase 2
• Start date: December 31, 2015
• Est. completion date: September 27, 2017

Study information

• Verified date: November 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 27, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

Drug:
• Presatovir
Tablets administered orally or via nasogastric (NG) tube once daily
• Placebo
Tablets administered orally or via NG tube once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7	The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.	Up to 7 days
Secondary	Percent Change From Study Baseline in FEV1% Predicted Value	FEV1 is defined as forced expiratory volume in the first second.	Baseline; Day 28