Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Phase 2
Completed
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: normal saline
- Registration Number
- NCT00658086
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief Summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 normal saline Normal saline 1 ALN-RSV01 ALN-RSV01
- Primary Outcome Measures
Name Time Method Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV Day 30
- Secondary Outcome Measures
Name Time Method Evaluate effects of ALN-RSV01 on clinical and virologic endpoints Throughout Trial
Trial Locations
- Locations (1)
Clinical Site
🇦🇺Perth, Western Australia, Australia