Clinical trial NCT00658086: Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Official title: A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: ALN-RSV01
Respiratory Syncytial Virus
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients


Eligibility criteria: Inclusion Criteria:

* Single or bilateral lung transplant recipients
* Confirmed RSV infection
* Greater than 90 days post current lung transplant
* Rejection free for a minimum of 1 month

Exclusion Criteria:

* Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
* 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

Primary outcomes:
measure: Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
timeFrame: Day 30
Secondary outcomes:
measure: Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
timeFrame: Throughout Trial
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Site
state: California
city: San Francisco
country: United States
facility: Clinical Site
state: California
city: Denver
country: United States
facility: Clinical Site
state: Colorado
city: Gainesville
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Site
state: Minnesota
city: Cleveland
country: United States
facility: Clinical Site
state: Ohio
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Sydney
country: Australia
facility: Clinical Site
state: New South Wales
city: Brisbane
country: Australia
facility: Clinical Site
state: Queensland
city: Perth
country: Australia
facility: Clinical Site
state: Western Australia
Study officials:
affiliation: University of Colorado Health Science Center
name: Martin Zamora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's Hospital NSW Australia
name: Allan Glanville, MB BS MD Syd, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.