Clinical Trials List
Protocol NumberGS-US-218-1502
NCT Number(ClinicalTrials.gov Identfier)NCT02254421
2016-11-01 - 2017-06-05
Phase II
Terminated1
Study ended1
ICD-10B97.4
Respiratory syncytial virus as the cause of diseases classified elsewhere
ICD-9079.6
Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site
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
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences, Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Su-Peng Yeh 未分科
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Condition/Disease
Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
Objectives
The primary objective of this study is as follows:
To evaluate the effect of presatovir on RSV viral load in
autologous or allogeneic HCT recipients with an acute RSV lower
respiratory tract infection (LRTI)
The secondary objectives of this study are as follows:
To evaluate the effect of presatovir on being free of any
supplemental oxygen, and rates of respiratory failure and
all-cause mortality
To evaluate the pharmacokinetics (PK), safety, and tolerability of
presatovir
Test Drug
GS-5806 (Presatovir)
Active Ingredient
Presatovir
Dosage Form
tablet
Dosage
50
Endpoints
Primary Endpoint:
Treatment with presatovir resulted in lower mean AUC viral load from initial dose through
end of quarantine. Viral load was assessed twice daily using nasal washes. The mean AUC
of viral load as measured by the RT-qPCR assay from first viral load measurement post
initial dose of study drug through Day 12 was significantly lower in presatovir subjects
compared to placebo subjects (Δ= 506.9 log10 PFUe*hour/mL, p <0.001).
Secondary Endpoints:
Treatment with presatovir resulted in lower mean AUC viral load during the entire
quarantine period. The mean AUC of viral load post challenge through Study Day 12 as
measured by the RT-qPCR assay was significantly lower in presatovir subjects compared to
placebo subjects (Δ= 531.0 log10 PFUe*hour/mL, p=<0.001).
Treatment with presatovir resulted in lower mean total mucus weight during dosing. The
average weight of each unused tissue was determined prior to start of study. The daily mucus
weight was calculated by first counting the number of tissues used each day, then subtracting
the total weight of these tissues, unused, from the daily total weight of used tissues. The
mean total weight of mucus produced post-initial dose of study drug through the dose was
significantly lower in the presatovir subjects compared to placebo subjects (Δ= 8.2 g,
p=0.028).
Treatment with presatovir resulted in a lower mean AUC of change from Baseline in total
symptom score during the entire quarantine period. Ten symptoms (runny nose, stuffy nose,
sneezing, sore throat, earache, malaise [tiredness], cough, shortness of breath, headache, and
muscle and/or joint ache) were each scored from 0 (no symptoms) to 3 (quite bothersome
most/all of the time). Total symptom scores (0-30) were the average score of questions
answered by each subject, multiplied by 10. The mean AUC of change from Baseline in total
symptom score post initial dose of study drug through Study Day 12 was significantly lower
in the presatovir subjects compared to placebo subjects (Δ= 225.1 score*hour, p=0.005). The
total symptoms score AUC was also significantly lower for presatovir treated subjects.
Treatment with presatovir resulted in lower mean AUC viral load from initial dose through
end of quarantine. Viral load was assessed twice daily using nasal washes. The mean AUC
of viral load as measured by the RT-qPCR assay from first viral load measurement post
initial dose of study drug through Day 12 was significantly lower in presatovir subjects
compared to placebo subjects (Δ= 506.9 log10 PFUe*hour/mL, p <0.001).
Secondary Endpoints:
Treatment with presatovir resulted in lower mean AUC viral load during the entire
quarantine period. The mean AUC of viral load post challenge through Study Day 12 as
measured by the RT-qPCR assay was significantly lower in presatovir subjects compared to
placebo subjects (Δ= 531.0 log10 PFUe*hour/mL, p=<0.001).
Treatment with presatovir resulted in lower mean total mucus weight during dosing. The
average weight of each unused tissue was determined prior to start of study. The daily mucus
weight was calculated by first counting the number of tissues used each day, then subtracting
the total weight of these tissues, unused, from the daily total weight of used tissues. The
mean total weight of mucus produced post-initial dose of study drug through the dose was
significantly lower in the presatovir subjects compared to placebo subjects (Δ= 8.2 g,
p=0.028).
Treatment with presatovir resulted in a lower mean AUC of change from Baseline in total
symptom score during the entire quarantine period. Ten symptoms (runny nose, stuffy nose,
sneezing, sore throat, earache, malaise [tiredness], cough, shortness of breath, headache, and
muscle and/or joint ache) were each scored from 0 (no symptoms) to 3 (quite bothersome
most/all of the time). Total symptom scores (0-30) were the average score of questions
answered by each subject, multiplied by 10. The mean AUC of change from Baseline in total
symptom score post initial dose of study drug through Study Day 12 was significantly lower
in the presatovir subjects compared to placebo subjects (Δ= 225.1 score*hour, p=0.005). The
total symptoms score AUC was also significantly lower for presatovir treated subjects.
Inclution Criteria
Subjects must meet all of the following inclusion criteria at the time
of randomization to be eligible for participation in this study:
1. Males and females 18 to 75 years of age
2. Received an autologous or allogeneic HCT using any
conditioning regimen
3. 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 chest
X-ray. If chest X-ray is not available, a chest X-ray must be
obtained for Screening
4. Documented RSV in both the upper (eg, nasal swab,
nasopharyngeal swab, nasal wash) and lower (eg, induced
sputum, bronchoalveolar lavage [BAL], lung biopsy, but not
spontaneous sputum) respiratory tract as determined by local
testing (eg, polymerase chain reaction [PCR], direct fluorescence
antibody [DFA], respiratory viral panel [RVP] assay, or culture).
All samples must have been collected ≤ 6 days prior to Day 1, or
as determined at Screening as per Section 6.1.1.
5. An informed consent document signed and dated by the subject or
a legal guardian of the subject and investigator or his/her
designee. In Sweden ICFs signed by a legal guardian must also be
signed by a close relative of the subject.
6. A negative urine or serum pregnancy test is required for female
subjects (unless surgically sterile or greater than two years
post-menopausal)
7. Male and female subjects of childbearing potential must agree to
contraceptive requirements as described in Appendix 5
8. Willingness to complete necessary study procedures and have
available a working telephone or email
of randomization to be eligible for participation in this study:
1. Males and females 18 to 75 years of age
2. Received an autologous or allogeneic HCT using any
conditioning regimen
3. 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 chest
X-ray. If chest X-ray is not available, a chest X-ray must be
obtained for Screening
4. Documented RSV in both the upper (eg, nasal swab,
nasopharyngeal swab, nasal wash) and lower (eg, induced
sputum, bronchoalveolar lavage [BAL], lung biopsy, but not
spontaneous sputum) respiratory tract as determined by local
testing (eg, polymerase chain reaction [PCR], direct fluorescence
antibody [DFA], respiratory viral panel [RVP] assay, or culture).
All samples must have been collected ≤ 6 days prior to Day 1, or
as determined at Screening as per Section 6.1.1.
5. An informed consent document signed and dated by the subject or
a legal guardian of the subject and investigator or his/her
designee. In Sweden ICFs signed by a legal guardian must also be
signed by a close relative of the subject.
6. A negative urine or serum pregnancy test is required for female
subjects (unless surgically sterile or greater than two years
post-menopausal)
7. Male and female subjects of childbearing potential must agree to
contraceptive requirements as described in Appendix 5
8. Willingness to complete necessary study procedures and have
available a working telephone or email
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to
be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of 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 investigational RSV vaccines
after HCT
2. Use of a moderate or strong 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 medical history:
3. Pregnant, breastfeeding, or lactating females
4. Unable to tolerate nasal sampling required for this study, as
determined by the investigator
5. Known history of HIV/AIDS with a CD4 count < 200 cells/μL
within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the
investigator, may prevent adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of
randomization
8. 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
9. Clinically significant bacteremia or fungemia within 7 days prior
to Screening that has not been adequately treated, as determined
by the investigator
10. Clinically significant bacterial, fungal, or viral pneumonia within
2 weeks prior to Screening that has not been adequately treated, as
determined by the investigator
11. Excessive nausea/vomiting at screening, as determined by the
investigator, or an inability to swallow pills that precludes oral
administration of the IMP (for subjects without an NG tube in
place)
12. 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 allergies:
13. Known hypersensitivity or allergy to the IMP, its metabolites, or
formulation excipients (microcrystalline cellulose, mannitol,
croscarmellose sodium, magnesium stearate, polyvinyl alcohol,
titanium dioxide, polyethylene glycol and talc)
14. History of hypersensitivity, anaphylactic reaction,
Stevens-Johnson Syndrome, or toxic epidermal necrolysis
response to sulfa drugs
Related to laboratory results:
15. Creatinine clearance < 30 mL/min (calculated using the
Cockcroft-Gault method)
16. Clinically significant AST/ALT, as determined by the
investigator
17. Clinically significant total bilirubin (TB), as determined by the
investigator
be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of 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 investigational RSV vaccines
after HCT
2. Use of a moderate or strong 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 medical history:
3. Pregnant, breastfeeding, or lactating females
4. Unable to tolerate nasal sampling required for this study, as
determined by the investigator
5. Known history of HIV/AIDS with a CD4 count < 200 cells/μL
within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the
investigator, may prevent adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of
randomization
8. 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
9. Clinically significant bacteremia or fungemia within 7 days prior
to Screening that has not been adequately treated, as determined
by the investigator
10. Clinically significant bacterial, fungal, or viral pneumonia within
2 weeks prior to Screening that has not been adequately treated, as
determined by the investigator
11. Excessive nausea/vomiting at screening, as determined by the
investigator, or an inability to swallow pills that precludes oral
administration of the IMP (for subjects without an NG tube in
place)
12. 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 allergies:
13. Known hypersensitivity or allergy to the IMP, its metabolites, or
formulation excipients (microcrystalline cellulose, mannitol,
croscarmellose sodium, magnesium stearate, polyvinyl alcohol,
titanium dioxide, polyethylene glycol and talc)
14. History of hypersensitivity, anaphylactic reaction,
Stevens-Johnson Syndrome, or toxic epidermal necrolysis
response to sulfa drugs
Related to laboratory results:
15. Creatinine clearance < 30 mL/min (calculated using the
Cockcroft-Gault method)
16. Clinically significant AST/ALT, as determined by the
investigator
17. Clinically significant total bilirubin (TB), as determined by the
investigator
The Estimated Number of Participants
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Taiwan
20 participants
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Global
100 participants
