Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
NCT ID: NCT00658086
Last Updated: 2018-01-29
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
24 participants
INTERVENTIONAL
2008-04-30
2009-06-30
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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1
ALN-RSV01
ALN-RSV01
administered by nebulization once daily for 3 days
2
Normal saline
normal saline
administered by nebulization once daily for 3 days
Interventions
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ALN-RSV01
administered by nebulization once daily for 3 days
normal saline
administered by nebulization once daily for 3 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 1 month
Exclusion Criteria
* Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state 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) or thymoglobulin within 3 months of screening: concurrent use of \>= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
* active treament for acute graft rejection
18 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Alnylam Pharmaceuticals
Principal Investigators
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Martin Zamora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Health Science Center
Allan Glanville, MB BS MD Syd, FRACP
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital NSW Australia
Locations
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Clinical Site
San Diego, California, United States
Clinical Site
San Francisco, California, United States
Clinical Site
Denver, Colorado, United States
Clinical Site
Gainesville, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Minneapolis, Minnesota, United States
Clinical Site
Cleveland, Ohio, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Site
Sydney, New South Wales, Australia
Clinical Site
Brisbane, Queensland, Australia
Clinical Site
Perth, Western Australia, Australia
Countries
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References
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Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17.
Other Identifiers
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ALN-RSV01-106
Identifier Type: -
Identifier Source: org_study_id
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