A Phase 2 clinical trial investigating GS-5806 in adult Lung Transplant (LT) recipients with Respiratory Syncytial Virus (RSV) Infectio
- Conditions
- Respiratory Syncytial Virus (RSV) InfectionMedDRA version: 18.1Level: LLTClassification code 10039247Term: RSV infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-002287-16-BE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1) Males and females = 18 years of age who have received a LT (single or double) or heart/lung transplant > 90 days prior to Screening
2) 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 IMP administration on Day 1/Baseline
3) 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
4) An informed consent document signed and dated by the subject
5) A negative urine or serum pregnancy test for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopause) at Screening or prior to Randomization on Day 1/Baseline
6) Agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception as described in Appendix 6 of the protocol
7) Ability and willingness to complete necessary study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
Related to concomitant or previous medication use:
1) Use of any 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
2) 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
3) Use of any of the following lympholytic treatment within the stated time frame: anti-thymocyte globulin (ATG), < 3 months; anti-lymphoblast globulin (ALG), < 3 months; muronomab-CD3 (OKT3), < 3 months; rituximab < 6 months; alemtuzumab < 9 months
Related to transplant history:
4) Recipient of any other organ transplant prior to Screening, with the exception of a LT (single or double) or heart/lung transplant
5) Recipient of a hematopoietic cell transplant at any time
6) Presence of bronchiolitis obiliterans syndrome (BOS) Stage 3 at Screening defined as a FEV1 of 50% or less of baseline
Related to medical condition at Screening:
7) Respiratory failure requiring invasive mechanical ventilation
8) Evidence of shock requiring vasopressors
9) 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
10) 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
11) Pregnant or lactating females
12) Evidence of recent and rapidly deteriorating lung function, occurring before the onset of the current viral respiratory infection, including but not limited to: acute lung allograft rejection, rapidly-progressive CLAD, and rCLAD (as determined by the investigator)
13) Any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints
Related to allergies:
14) 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)
15) History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic epidermal necroylsis response to sulfa drugs
Related to laboratory values:
16) 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.
17) Clinically significant liver function test abnormalities as defined by a ALT or AST > 5 times the ULN obtained in screening laboratory measurements or via local laboratory measurements obtained = 7 days prior to Screening
18) Clinically signi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the effect of presatovir on nasal RSV viral load in RSV-positive LT recipients with acute respiratory symptoms;Secondary Objective: - To evaluate the effect of presatovir on clinical sequelae of RSV infection and on measures of lung function<br>- To evaluate the pharmacokinetics (PK), safety, and tolerability of presatovir;Primary end point(s): The co-primary efficacy endpoints are:<br>- The time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) as measured in nasal samples by RT-qPCR among subjects in the FAS<br>- Time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) as measured in nasal samples by RT-qPCR in a subset of FAS subjects whose duration of RSV symptoms prior to the first dose of study medication is = median;Timepoint(s) of evaluation of this end point: Day 1 and Day 7
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time-weighted average change in FLU-PRO score from Day 1/Baseline through Day 7<br>- Percent change from Day 1/Baseline in FEV1% predicted value at Day 28/End of Study;Timepoint(s) of evaluation of this end point: Day 1 and Day 7<br>Day 1 and Day 28