A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:9/14/2018
Start Date:January 5, 2018
End Date:April 30, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the
clinical diagnosis of asthma and the frequency of wheezing in infants and children with
respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo)
and have completed their last planned study‑related visit in a feeding Phase 2 study
(64041575RSV2004).

RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis
is that treatment of RSV-infected infants/children with lumicitabine (also known as
JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo
(looks like lumicitabine). The participants who have completed treatment course
(lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the
treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this
study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in
infants/children with a history of RSV infection. The participants will be assessed via
monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.

Inclusion Criteria:

- Male or female infants and children who were previously randomized in study
64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and
who completed the planned course of the study drug and the last study-related visit of
study 64041575RSV2004

- The participant'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 participant to participate in the study

Exclusion Criteria:

- The participants legally acceptable representative, i.e, parent/legal
guardian/caregiver, is not able to maintain reliable communication with the
investigator

- Any condition for which, in the opinion of the investigator, participation would not
be in the best interest of the participant (example, compromise the well-being) or
that could prevent, limit, or confound the protocol-specified assessments
We found this trial at
23
sites
2015 Uppergate Drive
Atlanta, Georgia 30322
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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101 Manning Drive
Chapel Hill, North Carolina 27599
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Durham, North Carolina 27710
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2801 Atlantic Ave
Long Beach, California 90806
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Louisville, KY
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Madison, Wisconsin 53792
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Memphis, Tennessee 38103
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1 University Place
Shreveport, Louisiana 71130
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4 Technology Drive
Stony Brook, New York 11794
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750 East Adams Street
Syracuse, New York 13210
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