Respiratory Syncytial Virus Infections
Conditions
Keywords
ALN-RSV01, Respiratory Syncytial Virus
Brief summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
Interventions
DRUGALN-RSV01
administered by nebulization once daily for 3 days
DRUGnormal saline
administered by nebulization once daily for 3 days
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV | Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate effects of ALN-RSV01 on clinical and virologic endpoints | Throughout Trial |
Countries
Australia, United States
Outcome results
None listed