A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.
- Conditions
- Respiratory Syncytial Virus InfectionMedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-001653-40-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 216
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. Men or women =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), defined at the time of randomization.
2. Hospitalized (or in emergency room prior to hospitalization) at the
time of randomization and unlikely to be discharged for the first 24
hours after randomization.
3. Criterion modified per Amendment 2:
3.1 Diagnosed with RSV infection based on polymerase chain reaction
(PCR)-based assay with or without co-infection with another respiratory
pathogen (eg, influenza, human metapneumovirus, or bacteria).
4. Criterion modified per Amendment 2:
4.1 Has an acute respiratory illness with signs and symptoms consistent
with a viral infection (eg, fever, cough, nasal congestion, runny nose,
sore throat, myalgia, lethargy, shortness of breath, or wheezing) with
onset =5 days from the anticipated time of randomization.
5. Criterion modified per Amendment 2:
5.1 With the exception of the RSV disease, medically stable on the basis
of medical history, physical examination, vital signs, and 12-lead ECG
performed at screening. If there are abnormalities, they must be
consistent with the underlying illness in the study population and/or
RSV infection. This determination must be recorded in the subject's
source documents and initialed by the investigator.
6. Medically stable on the basis of clinical laboratory tests performed at
screening. If the results of the serum chemistry, haematology, or
urinalysis are outside the normal reference ranges, the subject may be
included only if the investigator judges the abnormalities or deviations
from normal do not pose an unacceptable risk to the subject, are not
clinically significant, or are appropriate and reasonable for the
population under study. This determination must be recorded in the
subject's source documents and initialed by the investigator. A single
repeat laboratory evaluation is allowed for eligibility determination.
7. Must sign an ICF (or their legally acceptable representative must sign)
indicating that he or she understands the purpose of, and procedures
required for, the study and is willing to participate in the study.
8. Criterion modified per Amendment 2:
8.1 A woman must have a negative urine ß-human chorionic
gonadotropin at screening.
9. Criterion modified per Amendment 2:
9.1 Contraceptive use by women should be consistent with local
regulations regarding the use of contraceptive methods for subjects
participating in clinical studies.
Before randomization, a woman must be either:
a. Not of childbearing potential defined as:
• Postmenopausal: a postmenopausal state is defined as >45 years and
no menses for 12 consecutive months without an alternative medical
cause, OR
• Permanently sterile: permanent sterilization methods include
hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation
procedures (without reversal operation), and bilateral oophorectomy.
b. Of childbearing potential and, if heterosexually active,
• Practicing a highly effective method of contraception (failure rate of
<1% per year when used consistently and correctly)
• Agrees to remain on a highly effective method throughout the study
and for at least 44 days after the last dose of study drug.
10. Criterion modified per Amendment 2:
10.1 Contraceptive use by men should be consistent with local
regulat
4.2. Exclusion Criteria
Any potential subject who meets any of the following criteria will be
excluded from participating in the study:
1. Subjects who are not expected to survive for more than 48 hours.
2. Subjects who have had major thoracic or abdominal surgery in the 6
weeks prior to randomization.
3. Criterion modified per Amendment 2:
3.1 Subjects who are considered by the investigator to be
immunocompromised within the past 12 months, whether due to
underlying medical condition (e.g., malignancy or genetic disorder) or
medical therapy (e.g., medications other than corticosteroids for the
treatment of COPD or asthma exacerbations, chemotherapy, radiation,
stem cell or solid organ transplant).
4. Subjects with a known history of human immunodeficiency virus
(HIV) or chronic viral hepatitis.
5. Subjects with ALT =3 times the upper limit of normal (ULN) AND
bilirubin =2×ULN (direct >35%) OR ALT =5×ULN at screening.
6. Criterion modified per Amendment 2:
6.1 Subjects undergoing peritoneal dialysis, haemodialysis, or
hemofiltration or with an estimated glomerular filtration rate (GFR,
determined by Chronic Kidney Disease Epidemiology Collaboration
[CKDEPI] equation) of <60 mL/min/1.73m2.
7. Known allergies, hypersensitivity, or intolerance to ALS-008176 or its
excipients (refer to the IB).
8. Criterion deleted per Amendment 2
9. Subjects unwilling to undergo mid-turbinate nasal swab procedures or
with any physical abnormality which limits the ability to collect regular
nasal specimens.
10. Subjects unable to take medications enterally or with a known
gastrointestinal-related condition that is considered by the sponsor or
investigator to be likely to interfere with study drug absorption.
11. Women who are pregnant or breastfeeding.
12. Criterion modified per Amendment 2:
12.1 Men who plan to father a child while enrolled in this study or within
104 days after the last dose of study drug.
13. Subjects taking any disallowed therapies as noted in Section 8 before
the planned first dose of study drug.
14. Criterion modified per Amendment 2:
14.1 Subjects who received prescription medications intended to prevent
or treat the RSV infection itself (eg, ribavirin, IV immunoglobulin,
palivizumab), an investigational drug, an investigational vaccine, or used
an invasive investigational medical device within 30 days or 5 half-lives
(whichever is longer) before the planned first dose of study drug or is
currently enrolled in an investigational study.
15. Subjects with any condition for which, in the opinion of the
investigator, participation would not be in the best interest of the
subject (e.g., compromise the well-being) or that could prevent, limit, or
confound the protocol-specified assessments.
16. Subjects who have used systemic corticosteroids for >7 consecutive
days immediately prior to randomization at doses higher than 20
mg/day of prednisone or equivalent.
17. Subject is being treated with extracorporeal membrane oxygenation.
18. Subjects with 1 or more of the following laboratory abnormalities at
screening as defined by the Division of Microbiology and Infectious
Diseases (DMID) Adult Toxicity Table:
- Hemoglobin <9.5 g/dL
- Platelet count <75,000/mm³
- White blood cell count <1,000/mm³
- Absolute neutrophil count <1,000/mm³
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method