Clinical trial NCT01065935: Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Official title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety 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
RSV
Respiratory Syncytial Virus
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 87
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 efficacy and safety of ALN-RSV01 plus standard of care 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 30 days

Exclusion Criteria:

* Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis
* 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

Primary outcomes:
measure: The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
timeFrame: 180 days after randomization
Secondary outcomes:
measure: Proportion of patients with FEV1 >80% of pre-infection baseline value
timeFrame: 90 and 180 days after randomization
measure: RSV symptoms as measured by mean cumulative daily total symptom score
timeFrame: 14 days after randomization
measure: Viral load as measured by viral area under the curve (AUC)
timeFrame: 6 days after randomization
measure: All cause mortality
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Los Angeles
country: United States
facility: Clinical Site
state: California
city: Denver
country: United States
facility: Clinical Site
state: Colorado
city: Tampa
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: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Site
state: Michigan
city: Saint Louis
country: United States
facility: Clinical Site
state: Missouri
city: New York
country: United States
facility: Clinical Site
state: New York
city: Cleveland
country: United States
facility: Clinical Site
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Site
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Houston
country: United States
facility: Clinical Site
state: Texas
city: Darlinghurst
country: Australia
facility: Clinical Site
state: New South Wales
city: Adelaide
country: Australia
facility: Clinical Site
state: South Australia
city: Melbourne
country: Australia
facility: Clinical Site
state: Victoria
city: Perth
country: Australia
facility: Clinical Site
state: Western Australia
city: Vienna
country: Austria
facility: Clinical Site
city: Edmonton
country: Canada
facility: Clinical Site
state: Alberta
city: Toronto
country: Canada
facility: Clinical Site
state: Ontario
city: Paris
country: France
facility: Clinical Site
city: Strasbourg Cedex
country: France
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Essen
country: Germany
facility: Clinical Site
city: Hamburg
country: Germany
facility: Clinical Site
city: Hannover
country: Germany
facility: Clinical Site
city: Homburg/Saar
country: Germany
facility: Clinical Site
city: Leipzig
country: Germany
facility: Clinical Site
Study officials:
affiliation: University of Colorado, Denver
name: Martin Zamora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincents Hospital NSW W Australia
name: Alan Glanville, MB BS MD Syd, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Jens T Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References: