A long-term follow-up of study 64041575RSV2004 to investigate the effects of lumicitabine (JNJ-64041575) in infants and children with a history of Respiratory Syncytial Virus infectio
- Conditions
- Respiratory syncytial virus infectionTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2016-002095-26-IT
- Lead Sponsor
- JANSSEN CILAG INTERNATIONAL NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7
1. Male or female infants and children who were previously randomized in Study 64041575RSV2004 for the treatment of RSV infection and who completed the planned course of the study drug and the last study-related visit of Study 64041575RSV2004.
2. The subject’s legally acceptable representative must sign an informed consent form (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:
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 of subjects for this age range
1. The subject’s legally acceptable representative, ie, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator.
2. 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