Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
NCT ID: NCT01065935
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2010-02-28
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALN-RSV01
ALN-RSV01
Administered by nebulization once daily for 5 days
Normal saline
Normal Saline
Administered by nebulization once daily for 5 days
Interventions
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ALN-RSV01
Administered by nebulization once daily for 5 days
Normal Saline
Administered by nebulization once daily for 5 days
Eligibility Criteria
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Inclusion Criteria
* Confirmed RSV infection
* Greater than 90 days post current lung transplant
* Rejection free for a minimum of 30 days
Exclusion Criteria
* Bronchiolitis obliterans syndrome (BOS) Grade 3 or any BOS with FEV1 that has not been stable for at least 3 months
* Use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (ATG) within 90 days of screening or prednisone or equivalent as maintenance therapy
* Active treatment for acute graft rejection
18 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Zamora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Alan Glanville, MB BS MD Syd, FRACP
Role: PRINCIPAL_INVESTIGATOR
St. Vincents Hospital NSW W Australia
Jens T Gottlieb, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Clinical Site
Phoenix, Arizona, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Denver, Colorado, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Ann Arbor, Michigan, United States
Clinical Site
St Louis, Missouri, United States
Clinical Site
New York, New York, United States
Clinical Site
Cleveland, Ohio, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Pittsburgh, Pennsylvania, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Darlinghurst, New South Wales, Australia
Clinical Site
Adelaide, South Australia, Australia
Clinical Site
Melbourne, Victoria, Australia
Clinical Site
Perth, Western Australia, Australia
Clinical Site
Vienna, , Austria
Clinical Site
Edmonton, Alberta, Canada
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Paris, , France
Clinical Site
Strasbourg, , France
Clinical Site
Berlin, , Germany
Clinical Site
Essen, , Germany
Clinical Site
Hamburg, , Germany
Clinical Site
Hanover, , Germany
Clinical Site
Homburg/Saar, , Germany
Clinical Site
Leipzig, , Germany
Countries
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Other Identifiers
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ALN-RSV01-109
Identifier Type: -
Identifier Source: org_study_id
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