A Study of ALS-008176 in Infants and Children Hospitalized with RSV
- Conditions
- Respiratory Syncytial Virus InfectionMedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-001641-79-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
1. Male or female infant who is =28 days to =36 months of age, inclusive, 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. Diagnosed with RSV infection based on a PCR-based molecular diagnostic assay (Note: in cases where commercial PCR-based assays are not available at the site, the sponsor should be consulted for agreement on the assay to be used) with or without co-infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria).
4. The time of onset of RSV symptoms to the time of randomization must be =5 days. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection. At the recommendation of the IDMC, this duration may be decreased or increased to up to 7 days. If this occurs, the Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs) will be notified promptly, without the need for a formal protocol amendment.
5. With the exception of the RSV-related illness or defined comorbid condition for severe RSV bronchiolitis (prematurity at birth [for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down Syndrome, neuromuscular impairment, or cystic fibrosis) the subject must be medically stable on the basis of physical examination, medical history, vital signs, and ECG performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population. 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 panel or hematology are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study (RSV-related illness or defined comorbid conditions for severe RSV bronchiolitis). 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. Estimated glomerular filtration rate (GFR) is not below the lower limit of normal for the subject’s age (Schwartz equation calculation).
8. In the investigator’s opinion, the subject’s legally acceptable representative understands and is able to comply with protocol requirements, instructions, and protocol stated restrictions, and subject is likely to complete the study as planned.
9. Their legally acceptable representative must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the subject to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number o
1. Subject has known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as known human immunodeficiency virus infection.
2. Receipt of (within the last 12 months) or currently on a waiting list for a bone marrow, stem cell or solid organ transplant, receipt of radiation or chemotherapy within 12 months prior to screening, or currently taking immunosuppressive medication.
3. Subjects who are anticipated to be treated with other agents with potential antiviral activity against RSV (eg, ribavirin, IV immunoglobulin, palivizumab).
4. History of or concurrent illness (beyond a defined comorbid condition for severe RSV bronchiolitis) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol-specified assessments such as liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, metabolic disturbances, or genetic diseases that result in immunosuppression. These may include, but are not limited to bacteremia, organ dysfunction, or other severe comorbidities.
5. Poorly functioning gastrointestinal tract (ie, unable to absorb drugs or nutrition via enteral route). Note: the use of IV fluids is not exclusionary so long as the investigator believes the subject’s gastrointestinal tract still functions properly (ie, is able to absorb drugs or nutrition).
6. Subject is being treated with extracorporeal membrane oxygenation.
7. Subject receiving chronic oxygen therapy at home prior to admission.
8. Taking any disallowed therapies before the planned first dose of study drug.
9. Received 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.
10. Planned or current participation in another interventional clinical study during this study.
11. Known allergies, hypersensitivity, or intolerance to ALS-008176 or its excipients.
12. Being breastfed by a mother taking any of the excluded medications.
13. Subject’s legally acceptable representative ie, parent(s)/legal guardian/caregiver(s), is not able to communicate reliably with the investigator.
14. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
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