NCT00658086CompletedPhase 2
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)
Alnylam Pharmaceuticals1 site in 1 country24 target enrollmentStarted: April 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Study Overview
Brief Summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Active Comparator
ALN-RSV01
Intervention: ALN-RSV01 (Drug)
2
Placebo Comparator
Normal saline
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Time Frame: Day 30
Secondary Outcomes
- Evaluate effects of ALN-RSV01 on clinical and virologic endpoints(Throughout Trial)
Investigators
Study Sites (1)
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