A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.

Phase 1

• Conditions: Respiratory Syncytial Virus Infection; MedDRA version: 20.0Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001653-40-SE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-09
• Study Completion: 2018-10-17
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. Criterion modified per Amendment 2/SWE-1:
1.1. Men or women =18 years of age, 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/SWE-1:
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/SWE-1:
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/SWE-1:
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 the 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 and next of kin 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/SWE-1:
8.1. A woman must have a negative urine ß-human chorionic gonadotropin at screening.
9. Criterion modified per Amendment 2/SWE-1:
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. Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in c

Exclusion Criteria

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/SWE-1:
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/SWE-1:
6.1. Subjects undergoing peritoneal dialysis, haemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 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/SWE-1.
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. 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/SWE-1:
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